Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-30 (of 37 Records) |
Query Trace: Gallo MF[original query] |
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Combination injectable contraceptives for contraception
Gallo MF , Grimes DA , Schulz KF , d'Arcangues C , Lopez LM . Cochrane Database Syst Rev 2005 (3) Cd004568 BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials reported in any language were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: The primary reviewer evaluated all titles and abstracts from the literature searches to determine their eligibility. Two reviewers independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan 4.2. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These combination injectable contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems, but had higher rates of discontinuation due to other reasons than the progestin-only comparison contraceptives. Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall early discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials making this comparison. The NET-EN plus E(2)V group also had more cyclical (regular) bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation rates are dependent on many other factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinical sites, methods for women to administer their own injections, and counseling about possible bleeding pattern changes. |
Combination injectable contraceptives for contraception
Gallo MF , Grimes DA , Lopez LM , Schulz KF , d'Arcangues C . Cochrane Database Syst Rev 2008 2008 (4) Cd004568 BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from the literature searches to determine their eligibility. Two authors independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the combination injectable in one study and the progestin-only in another.Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E(2)V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes. |
Prepregnancy and gestational diabetes and cessation of breastfeeding <1 week postpartum, United States, 2016-2018
Kortsmit K , Boone KI , Warner L , Horan J , Bower JK , Gallo MF . Public Health Rep 2022 138 (3) 333549221099082 OBJECTIVES: Diabetes may delay milk letdown, and perceiving milk production as insufficient can lead to breastfeeding cessation. We evaluated whether prepregnancy or gestational diabetes is associated with cessation of breastfeeding by 1 week postpartum. METHODS: We analyzed 2016-2018 data from 42 sites in the Pregnancy Risk Assessment Monitoring System, a population-based survey of women with a recent live birth. Participants were surveyed 2-6 months after childbirth. We used logistic regression models to evaluate the relationship between prepregnancy or gestational diabetes only and breastfeeding <1 week postpartum among women who had initiated breastfeeding. RESULTS: Among 82 050 women who initiated breastfeeding, 4.5% reported breastfeeding <1 week postpartum. Overall, 11.7% of women reported any history of diabetes in the 3 months before becoming pregnant; 3.3% reported prepregnancy diabetes, and 8.4% reported gestational diabetes only. In both unadjusted and adjusted models, the prevalence of breastfeeding <1 week postpartum did not differ significantly among women with prepregnancy diabetes or gestational diabetes only compared with women without any history of diabetes. The prevalence of breastfeeding <1 week postpartum was 4.4% among women without any history of diabetes, 5.6% among women with prepregnancy diabetes (adjusted prevalence ratio [aPR] = 1.15; 95% CI, 0.91-1.46), and 4.5% among women with gestational diabetes only (aPR = 1.01; 95% CI, 0.84-1.20). CONCLUSIONS: We found no association between a history of diabetes prepregnancy or gestational diabetes only and breastfeeding <1 week postpartum in a large, population-based survey of postpartum women who initiated breastfeeding. Regardless of their diabetes status, women who want to breastfeed might benefit from interventions that support their ability to continue breastfeeding. |
Sexual relationship power and semen exposure among female patients at a sexually transmitted infection clinic in Kingston, Jamaica
Gallo MF , Legardy-Williams J , Steiner MJ , Macaluso M , Carter M , Hobbs MM , Hylton-Kong T , Anderson C , Costenbader E , Warner L . Arch Sex Behav 2016 46 (7) 2157-2164 Women's power in sexual relationships is thought to be an important predictor of condom use. However, research on correlates of condom use often relies on participant reporting of behavior, which has questionable validity. We evaluated the association between scores from the modified Sexual Relationship Power Scale (SRPS-M) and biological detection of semen exposure in a prospective study of adult women attending a sexually transmitted infection clinic in Kingston, Jamaica with cervicitis or abnormal vaginal discharge in 2010-2011. At enrollment, women were counseled to avoid sex while on treatment and were asked to return in 6 days for a follow-up visit. At both study visits, women were administered a questionnaire and had vaginal swabs collected to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure. We found no significant association at enrollment or follow-up between SRPS-M scores and semen exposure, as measured with either self-reported data or PSA positivity. Semen biomarkers could be used to develop and validate new scales on relationship power and self-efficacy related to condom use. |
Association of progestin contraceptive implant and weight gain
Gallo MF , Legardy-Williams J , Hylton-Kong T , Rattray C , Kourtis AP , Jamieson DJ , Steiner MJ . Obstet Gynecol 2016 127 (3) 573-576 OBJECTIVE: To evaluate initiation of a two-rod, 150-mg levonorgestrel contraceptive implant on women's perceived and observed body weight. METHODS: We conducted a secondary analysis of data from an open, randomized controlled trial of adult, nonpregnant, human immunodeficiency virus-negative women attending a public clinic in Kingston, Jamaica, who were assigned to initiate implant use either immediately or after a 3-month delay. The primary objective of the parent study was to assess the effect of initiation of the implant on the frequency of condom use. We compared study arms during follow-up using one-sided chi tests for differences in perceived weight gain and loss, one-sided Wilcoxon-Mann-Whitney tests for median gain in measured weight, and logistic regression with generalized estimating equations for risk of gaining greater than 2 kg. RESULTS: From 2012 to 2014, women were assigned to the implant (n=208) or delay arm (n=206). At 3 months, more women in the implant arm (15.3%) reported perceived weight gain than in the control arm (4.3%) (P=.01). Despite differences in perception, the implant and control arms did not differ significantly in median weight gain at 1-month (0.0 kg and 0.0 kg, respectively; P=.44) and 3-month visits (0.5 kg and 0.0 kg, respectively; P=.27). Study arms did not differ in risk of gaining greater than 2 kg (odds ratio 0.9, 95% confidence interval 0.6-1.3). CONCLUSION: We found no evidence of weight gain from short-term implant use. Through the power of the nocebo effect, the practice of counseling women to expect possible weight gain from initiating implant use could lead them to perceive weight gain even in its absence and contribute to the early discontinuation of this highly effective contraceptive method. |
Recent biomarker-confirmed unprotected vaginal sex, but not self-reported unprotected sex, is associated with recurrent bacterial vaginosis
Turner AN , Carr Reese P , Snead MC , Fields K , Ervin M , Kourtis AP , Klebanoff MA , Gallo MF . Sex Transm Dis 2016 43 (3) 172-6 BACKGROUND: Self-reported unprotected vaginal sex seems to increase risk of bacterial vaginosis (BV). However, the validity of self-reports is questionable, given their inconsistency with more objective measures of recent semen exposure such as detection of prostate-specific antigen (PSA). We examined whether recent unprotected sex, as measured both by PSA detection on vaginal swabs and by self-report, was associated with increased BV recurrence. METHODS: We analyzed randomized trial data from nonpregnant, BV-positive adult women recruited from a sexually transmitted disease clinic. Participants received BV therapy at enrollment and were scheduled to return after 4, 12, and 24 weeks. Bacterial vaginosis (by Nugent score) and PSA were measured at each visit. We used Cox proportional hazards models to examine the association between PSA positivity and recurrent BV. We also evaluated associations between self-reported unprotected sex (ever/never since the last visit and in the last 48 hours, analyzed separately) and recurrent BV. RESULTS: Prostate-specific antigen and BV results were available for 96 women who contributed 226 follow-up visits. Prostate-specific antigen positivity was associated with increased BV recurrence (adjusted hazard ratio [aHR], 2.32; 95% confidence interval [CI], 1.28-4.21). In contrast, we observed no significant increase in BV recurrence among women self-reporting unprotected sex since the last visit (aHR, 1.63; 95% CI, 0.77-3.43) or in the last 48 hours (aHR, 1.28; 95% CI, 0.70-2.36). CONCLUSIONS: Estimates from earlier studies linking self-reported unprotected sex and BV may be biased by misclassification. Biomarkers can improve measurement of unprotected sex, a critical exposure variable in sexual health research. |
Sexual abstinence and other behaviours immediately following a new STI diagnosis among STI clinic patients: Findings from the Safe in the City trial
Gallo MF , Margolis AD , Malotte CK , Rietmeijer CA , Klausner JD , O'Donnell L , Warner L . Sex Transm Infect 2015 92 (3) 206-10 BACKGROUND: Few studies have assessed patients' sexual behaviours during the period immediately following a new diagnosis of a curable sexually transmitted infection (STI). METHODS: Data were analysed from a behavioural study nested within the Safe in the City trial, which evaluated a video-based STI/HIV prevention intervention in three urban STI clinics. We studied 450 patients who reported having received a new STI diagnosis, or STI treatment, 3 months earlier. Participants reported on whether they seriously considered, attempted and succeeded in adopting seven sex-related behaviours in the interval following the diagnostic visit. We used multivariable logistic regression to identify, among men, correlates of two behaviours related to immediately reducing reinfection risk and preventing further STI transmission: sexual abstinence until participants were adequately treated and abstinence until their partners were tested for STIs. RESULTS: Most participants reported successfully abstaining from sex until they were adequately treated for their baseline infection (89%-90%) and from sex with potentially exposed partners until their partners were tested for HIV and other STIs (66%-70%). Among men who intended to be abstinent until they were adequately treated, those who did not discuss the risks with a partner who was possibly exposed were more likely not to be abstinent (OR, 3.7; 95% CI 1.5 to 9.0) than those who had this discussion. Similarly, among men who intended to abstain from sex with any potentially exposed partner until the partner was tested for HIV and other STIs, those who reported not discussing the risks of infecting each other with HIV/STIs were more likely to be sexually active during this period (OR, 3.5; 95% CI 1.6 to 8.1) than were those who reported this communication. CONCLUSIONS: Improved partner communication could facilitate an important role in the adoption of protective behaviours in the interval immediately after receiving a new STI diagnosis. TRIAL REGISTRATION NUMBER: NCT00137670. |
Effects of initiating a contraceptive implant on subsequent condom use: a randomized controlled trial
Rattray C , Wiener J , Legardy-Williams J , Costenbader E , Pazol K , Medley-Singh N , Snead MC , Steiner MJ , Jamieson DJ , Warner L , Gallo MF , Hylton-Kong T , Kourtis AP . Contraception 2015 92 (6) 560-6 OBJECTIVE: To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception (LARC), reduces condom use, as measured by a biomarker of recent semen exposure (prostate-specific antigen (PSA)). STUDY DESIGN: We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a three-month study period. Participants were tested for PSA at baseline and two follow-up study visits, and asked about their sexual activity and condom use. RESULTS: At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm (1-month: 26.1% vs. 20.2%; prevalence ratio (PR) = 1.3; (95% confidence interval (CI) = 0.9-1.9); 3-month: 25.6% vs. 23.1%; PR= 1.1; (95% CI = 0.8-1.6)). The change in PSA positivity over the 3 study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value=0.15). CONCLUSIONS: Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short-term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. IMPLICATIONS: Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant. |
Differences in misreporting of sexual behavior over time: implications for HIV trials
Gallo MF , Warner L , Hobbs MM , Jamieson DJ , Hylton-Kong T , Steiner MJ . Sex Transm Dis 2015 42 (3) 160-1 We used data from a prospective study of 300 women attending a sexually transmitted infection clinic in Kingston, Jamaica, to compare participant self-report of recent semen exposure to actual semen exposure measured by prostate-specific antigen in vaginal swabs. Underreporting of semen exposure was significantly more frequent at follow-up than baseline, suggesting that the accuracy of reports of sexual behavior may vary over time. |
Sexually transmitted disease partner notification among African-American, adolescent women
Buchsbaum A , Gallo MF , Whiteman MK , Cwiak C , Goedken P , Kraft JM , Jamieson DJ , Kottke M . Infect Dis Obstet Gynecol 2014 2014 619632 OBJECTIVE: To better understand preferences and practices regarding partner notification of sexually transmitted infection (STI) among female, African-American adolescents. METHODS: Participants completed a questionnaire and STI testing at baseline. Those diagnosed with Chlamydia or gonorrhea were recruited for a follow-up study, involving another questionnaire and repeat STI testing after three months. RESULTS: At baseline, most participants (85.1%) preferred to tell their partner about an STI diagnosis themselves instead of having a health care provider inform him, and 71.0% preferred to bring their partner for clinic treatment instead of giving him pills or a prescription. Two-thirds of participants were classified as having high self-efficacy for partner notification of a positive STI diagnosis. In the multivariable analysis, older participants and those with fewer lifetime sexual partners were more likely to have high self-efficacy. Ninety-three participants (26.6%) had Chlamydia or gonorrhea and, of this subset, 55 participated in the follow-up study. Most adolescents in the follow-up study (76.4%) notified their partner about their infection. CONCLUSION: Although participants were willing to use most methods of partner notification, most preferred to tell partners themselves and few preferred expedited partner therapy. Traditional methods for partner notification and treatment may not be adequate for all adolescents in this population. |
Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?
Snead MC , Kourtis AP , Melendez JH , Black CM , Mauck CK , Penman-Aguilar A , Chaney DM , Gallo MF , Jamieson DJ , Macaluso M , Doncel GF . Contraception 2014 90 (2) 136-41 OBJECTIVES: There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers prostate-specific antigen (PSA) or Y chromosome DNA. STUDY DESIGN: We tested (in vitro) dilutions of tenofovir (TFV), UC781 and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction. RESULTS: TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. CONCLUSIONS: The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. IMPLICATIONS: Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV UC781, or HEC. |
Fertility treatments and multiple births in the United States
Kulkarni AD , Jamieson DJ , Jones HW Jr , Kissin DM , Gallo MF , Macaluso M , Adashi EY . N Engl J Med 2013 369 (23) 2218-25 BACKGROUND: The advent of fertility treatments has led to an increase in the rate of multiple births in the United States. However, the trends in and magnitude of the contribution of fertility treatments to the increase are uncertain. METHODS: We derived the rates of multiple births after natural conception from data on distributions of all births from 1962 through 1966 (before fertility treatments were available). Publicly available data on births from 1971 through 2011 were used to determine national multiple birth rates, and data on in vitro fertilization (IVF) from 1997 through 2011 were used to estimate the annual proportion of multiple births that were attributable to IVF and to non-IVF fertility treatments, after adjustment for maternal age. Trends in multiple births were examined starting from 1998, the year when clinical practice guidelines for IVF were developed with an aim toward reducing the incidence of multiple births. RESULTS: We estimated that by 2011, a total of 36% of twin births and 77% of triplet and higher-order births resulted from conception assisted by fertility treatments. The observed incidence of twin births increased by a factor of 1.9 from 1971 to 2009. The incidence of triplet and higher-order births increased by a factor of 6.7 from 1971 to 1998 and decreased by 29% from 1998 to 2011. This decrease coincided with a 70% reduction in the transfer of three or more embryos during IVF (P<0.001) and a 33% decrease in the proportion of triplet and higher-order births attributable to IVF (P<0.001). CONCLUSIONS: Over the past four decades, the increased use of fertility treatments in the United States has been associated with a substantial rise in the rate of multiple births. The rate of triplet and higher-order births has declined over the past decade in the context of a reduction in the transfer of three or more embryos during IVF. |
Detection of two biological markers of intercourse: prostate-specific antigen and Y-chromosomal DNA
Jamshidi R , Penman-Aguilar A , Wiener J , Gallo MF , Zenilman JM , Melendez JH , Snead M , Black CM , Jamieson DJ , Macaluso M . Contraception 2013 88 (6) 749-57 BACKGROUND: Although biological markers of women's exposure to semen from vaginal intercourse have been developed as surrogates for risk of infection or probability of pregnancy, data on their persistence time and clearance are limited. STUDY DESIGN: During 2006-2008, 52 couples were enrolled for three 14-day cycles of abstinence from vaginal sex during which women were exposed in the clinic to a specific quantity (10, 100 or 1000 muL) of their partner's semen. Vaginal swabs were collected before and at 1, 6, 12, 24, 48, 72 and 144 h after exposure for testing for prostate-specific antigen (PSA) and Y-chromosome DNA (Yc DNA). RESULTS: Immediately after exposure to 1000 muL of semen, the predicted sensitivity of being PSA positive was 0.96; this decreased to 0.65, 0.44, 0.21 and 0.07 at 6, 12, 24 and 48 h, respectively. Corresponding predicted sensitivity of being Yc DNA positive was 0.72 immediately postexposure; this increased to 0.76 at 1 h postexposure and then decreased to 0.60 (at 6 h), 0.63 (at 12 h), 0.49 (at 24 h), 0.21 (at 48 h), 0.17 (at 72 h) and 0.12 (at 144 h). CONCLUSIONS: Overall findings suggest that PSA may be more consistent as a marker of very recent exposure and that Yc DNA is more likely to be detected in the vagina after 12 h postexposure compared to PSA. |
Evaluation of a volunteer community-based health worker program for providing contraceptive services in Madagascar
Gallo MF , Walldorf J , Kolesar R , Agarwal A , Kourtis AP , Jamieson DJ , Finlay A . Contraception 2013 88 (5) 657-65 BACKGROUND: Madagascar recently scaled up their volunteer community health worker (CHW) program in maternal health and family planning to reach remote and underserved communities. STUDY DESIGN: We conducted a cross-sectional evaluation using a systematic sample of 100 CHWs trained to provide contraceptive counseling and short-acting contraceptive services at the community level. CHWs were interviewed on demographics, recruitment, training, supervision, commodity supply, and other measures of program functionality; tested on knowledge of injectable contraception; and observed by an expert while completing five simulated client encounters with uninstructed volunteers. We developed a CHW performance score (0-100%) based on the number of counseling activities adequately met during the client encounters and used multivariable linear regression to identify correlates of the score. RESULTS: CHWs had a mean performance score of 73.9% (95% confidence interval [CI]: 70.3-77.6%). More education, more weekly volunteer hours, and receiving a refresher training correlated with a higher performance score. We found no other associations between measures of the components previously identified as essential for effective CHW programs and performance score. CONCLUSIONS: Although areas of deficiency were identified, CHWs proved capable of providing high-quality contraception services. |
Biological markers of sexual activity: tools for improving measurement in HIV/sexually transmitted infection prevention research
Gallo MF , Steiner MJ , Hobbs MM , Warner L , Jamieson DJ , Macaluso M . Sex Transm Dis 2013 40 (6) 447-52 Research on interventions to prevent HIV and other sexually transmitted infections (STIs) is heavily influenced by participant reporting of sexual behavior, despite uncertainty about its validity. Exclusive reliance on participant self-report often is based, overtly or by implication, on 4 assumptions: (1) no feasible alternatives exist; (2) misreporting can be minimized to levels that can be disregarded; (3) misreporting tends to underreport sensitive behaviors; and (4) misreporting tends to be nondifferential with respect to the groups being compared. The objective of this review are to evaluate these assumptions, including a review of studies using semen biomarkers to evaluate the validity of self-reported data, and to make recommendations for applying biological markers of semen exposure detectable in women to further strengthen research on HIV/STI prevention. Increasing evidence shows that semen biomarkers provide an important means of assessing and augmenting the validity of studies on HIV/STI prevention. Additional biomarkers are needed to assess male exposure to vaginal sex and both male and female exposure to anal sex. Methods and study designs that incorporate biomarkers into studies collecting self-reported behavioral data should be considered where possible. |
Combination injectable contraceptives for contraception
Gallo MF , Grimes DA , Lopez LM , Schulz KF , d'Arcangues C . Cochrane Database Syst Rev 2013 3 CD004568 BACKGROUND: Combination injectable contraceptives (CICs) provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of CICs. SEARCH METHODS: In January and February 2013, we searched for randomized controlled trials (RCTs) of combination injectable contraceptives. Databases include MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS. We searched for current trials in ClinicalTrials.gov and ICTRP.Earlier searches also included AIM and IMEMR. For the initial review, we also assessed the references listed in review articles and in the eligible trial reports. SELECTION CRITERIA: RCTs were eligible if they compared a combination injectable contraceptive with any other contraceptive method (e.g., a second CIC,a progestin-only injectable contraceptive, another hormonal contraceptive or a barrier method) or a placebo. We limited the review to marketed CICs. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data on contraceptive efficacy, bleeding patterns, continuation, and side effects. We calculated the Peto odds ratio or mean difference with 95% confidence interval for dichotomous or continuous outcome, respectively. Survival analysis estimates for method discontinuation were presented where available. MAIN RESULTS: Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA)25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons.Acceptability results favored the CIC in one study and the progestin-only in another. Studies comparing two CICs found that NET-EN 50 mg plus E(2)V (5)mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials.The NET-EN plus E (2) V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes. |
Randomized controlled trial on the effectiveness of counseling messages for avoiding unprotected sexual intercourse during sexually transmitted infection and reproductive tract infection treatment among female sexually transmitted infection clinic patients
Anderson C , Gallo MF , Hylton-Kong T , Steiner MJ , Hobbs MM , Macaluso M , Figueroa JP , Jamieson DJ , Legardy-Williams J , Wiener J , Warner L . Sex Transm Dis 2013 40 (2) 105-110 BACKGROUND: The effectiveness of counseling messages to avoid unprotected sex during short-term treatment for curable sexually transmitted infections is unknown. METHODS: We randomized 300 female STI clinic patients 18 years or older with cervicitis and/or vaginal discharge in Kingston, Jamaica, in 2010 to 2011, to 1 of 2 counseling messages for their course of syndromic treatment: abstinence only or abstinence backed up by condom use. At a follow-up visit 6 days afterward, we collected vaginal swabs to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure, and administered a questionnaire assessing sexual behavior. RESULTS: No differences were found in the proportions of women testing positive for PSA at follow-up in the abstinence-plus-condom group (11.9%) and abstinence-only group (8.4%) (risk difference, 3.5; 95% confidence interval, -3.5 to10.5). There also was no significant difference in reporting of unprotected sex between groups. Reporting a history of condom use before enrollment significantly modified the effect of counseling arm on PSA positivity (P = 0.03). Among those reporting recent condom use, 10.3% in the abstinence-only arm and 4.8% in the abstinence-plus-condom arm tested positive for PSA. Conversely, among those not reporting recent condom use, 6.5% in the abstinence-only arm and 17.3% in the abstinence-plus-condom arm had PSA detected. CONCLUSIONS: We found no evidence to support the superiority of either counseling message. Post hoc analyses suggest that women with recent condom experience may benefit significantly more from abstinence-plus-condom messages, whereas women without such experience may benefit significantly more from abstinence-only messages. Providers should weigh individual condom use history when determining the most appropriate counseling message. |
Effect of topical vaginal products on the detection of prostate-specific antigen, a biomarker of semen exposure, using ABAcards
Snead MC , Kourtis AP , Black CM , Mauck CK , Brown TM , Penman-Aguilar A , Melendez JH , Gallo MF , Jamieson DJ , Macaluso M . Contraception 2012 88 (3) 382-6 BACKGROUND: Prostate-specific antigen (PSA) is a biomarker of recent semen exposure. There is currently only limited information on whether topical vaginal products affect PSA assays. We investigated this question using various dilutions of several vaginal products (lubricants and spermicides) and the Abacus ABAcard for PSA detection. STUDY DESIGN: Pooled semen controls and various dilutions of nonoxynol-9 (N9), carboxymethyl cellulose (CMC), Replens, Gynol 2, K-Y jelly, Astroglide, Surgilube, combined with pooled semen dilutions, were tested for PSA using the Abacus ABAcard. RESULTS: N9 (2% with saline) and CMC did not appear to affect the results of testing with the ABAcard, but not all semen dilutions were tested. The other products (including Replens and Gynol, which is 2% N9 with propylene glycol, K-Y, Astroglide and Surgilube) at some of the dilutions tested either affected or gave invalid results with PSA testing using the ABAcard. Both Gynol 2 and K-Y at 1:10 dilution gave false-positive results. CONCLUSIONS: Some vaginal products affect PSA results obtained by using the semiquantitative ABAcard. In vivo confirmation is necessary to further optimize PSA detection when topical vaginal products are present. |
Optimal methods for collecting and storing vaginal specimens for prostate-specific antigen testing in research studies
Gallo MF , Snead MC , Black CM , Brown TM , Kourtis AP , Jamieson DJ , Carter M , Penman-Aguilar A , Macaluso M . Contraception 2012 87 (6) 830-5 BACKGROUND: Prostate-specific antigen (PSA) detected in vaginal fluid can be used in studies of HIV/sexually transmitted infection (STI) and pregnancy prevention as an alternative to relying on participant reports of exposure to semen. Optimal methods for collecting and storing specimens for this testing have not been determined. STUDY DESIGN: We conducted a controlled, in vitro experiment of 550 specimens spiked with semen to determine the effects of swab type (five types), storage conditions of the swabs (room temperature with or without desiccant or at -80 degrees C without desiccant) and time from collection to testing (seven intervals over the course of 12 months) on the identification of PSA. We performed factorial analysis of variance to identify factors influencing PSA detection. RESULTS: Concentrations of PSA detected in the swabs declined with time of storage over the 1-year experiment (p<.01). The 1-mL, rayon-tipped swab stored immediately at -80 degrees C following collection performed best. CONCLUSIONS: If immediate testing or freezer storage is not feasible, investigators should use a swab with 1-mL capacity with processing and testing as soon as possible after specimen collection. |
Condom type may influence sexual behavior and ejaculation and complicate the assessment of condom functionality
Haddad L , Gallo MF , Jamieson DJ , Macaluso M . Contraception 2012 86 (4) 391-6 BACKGROUND: Studies that evaluate condom effectiveness are affected by factors related to how the condom was used, and these factors may not be consistent between different types of condoms. Also, subjective assessments of the sexual act may be unreliable. STUDY DESIGN: We performed a secondary data analysis of a randomized crossover trial of male and female condoms among 108 couples. RESULTS: Self-reported duration and activeness of coital acts were significantly different for uses of the male condom compared to uses of the female condom. Fewer individuals reported ejaculation occurring with the female condom. Reliability of self-reports of ejaculation compared to a biological marker of semen detected inside the used male and female condoms was not strong. CONCLUSIONS: We found that sexual behaviors appear to differ by the type of condom used for the coital act. Studies should consider sexual behavior when evaluating condom effectiveness. Furthermore, studies would be strengthened by the use of a biological marker of semen to determine whether ejaculation, and therefore a true risk of exposure, occurred. |
Condom use around the globe: how can we fulfil the prevention potential of male condoms?
Warner L , Gallo MF , Macaluso M . Sex Health 2012 9 (1) 4-9 Despite a global epidemic of sexually transmissible infections and the availability and endorsement of condoms as an effective intervention, the overall use of condoms remains low. This review explores various challenges and opportunities to fully realizing the prevention potential for condoms. |
A review of the effectiveness and acceptability of the female condom for dual protection
Gallo MF , Kilbourne-Brook M , Coffey PS . Sex Health 2012 9 (1) 18-26 The female condom remains the sole female-initiated method of dual protection against unintended pregnancy and sexually transmissible infections (STIs), including HIV. We reviewed published data on the effectiveness and acceptability of the female condom for protection against pregnancy and infection. Overall, use of the female condom is low and several barriers hinder the wider adoption of the use of the method. Research on effectiveness has focussed on pregnancy, STIs and biological markers of semen exposure. Although the data available suggest that female condoms (or a mixture of female and male condoms) may provide similar degrees of protection against pregnancy and STIs as do latex male condoms alone, this conclusion has not been demonstrated and thus comparative research is urgently needed. |
Association between semen exposure and incident bacterial vaginosis
Gallo MF , Warner L , King CC , Sobel JD , Klein RS , Cu-Uvin S , Rompalo AM , Jamieson DJ . Infect Dis Obstet Gynecol 2011 2011 842652 OBJECTIVE: To identify correlates of incident bacterial vaginosis (BV) diagnosed with Nugent scoring among high-risk women. STUDY DESIGN: We conducted both cohort and case-crossover analyses, stratified by HIV infection status, based on 871 HIV-infected and 439 HIV-uninfected participants in the HIV Epidemiology Research Study, conducted in 4 US sites in 1993-2000. RESULTS: BV incidence was 21% and 19% among HIV-infected and -uninfected women, respectively. Fewer correlates of BV were found with case-crossover than with cohort design. Reporting frequent coitus (regardless of consistency of condom use) was correlated with BV in cohort analyses but not in case-crossover analyses. The sole correlate of BV in both types of analyses was the detection of spermatozoa on Gram stain, which is a marker of semen exposure. CONCLUSION: The inconsistent association between condom use and BV in prior studies could be from reporting bias. We found evidence of a relationship between semen exposure and incident BV. |
Bacterial vaginosis, gonorrhea, and chlamydial infection among women attending a sexually transmitted disease clinic: a longitudinal analysis of possible causal links
Gallo MF , Macaluso M , Warner L , Fleenor ME , Hook EW 3rd , Brill I , Weaver MA . Ann Epidemiol 2011 22 (3) 213-20 PURPOSE: Interactions between bacterial vaginosis (BV) and inflammatory sexually transmitted infections, such as gonorrhea and chlamydial infection, are not well understood. Furthermore, evidence regarding the sexual transmission of BV is equivocal. METHODS: We assessed associations between incident BV and incidences of gonorrhea and/or chlamydial infection ("gonorrhea/chlamydia"), as well as similarities in associations for the two processes, among 645 female patients at a sexually transmitted disease clinic in Alabama followed prospectively for 6 months from 1995 to 1998. We identified predictors of both incident BV and gonorrhea/chlamydia and used bivariate logistic regression to determine whether these predictors differed. RESULTS: Participants completed 3188 monthly, follow-up visits. Several factors associated with incident BV involved sexual intercourse: young age (<16 years) at first intercourse (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-1.9), recent drug use during sex (aOR, 1.7; 95% CI, 1.2-2.5), prevalent trichomoniasis (aOR, 2.8; 95% CI, 1.7-4.6) and incident syphilis (aOR, 9.7; 95% CI, 1.9-48.4). Few statistical differences between potential factors for BV and gonorrhea/chlamydia emerged. BV appeared to precede the acquisition of gonorrhea/chlamydia (pairwise odds ratio, 1.6; 95% CI, 1.1-2.3), and vice versa (pairwise odds ratio, 2.4; 95% CI, 1.7-3.5). CONCLUSIONS: Findings are consistent with a causal role of sexual behavior in the acquisition of BV and confirm that BV facilitates acquisition of gonorrhea/chlamydia and vice versa independently from other risk factors. |
Discordance between spermatozoa detection and self-reported semen exposure
Gallo MF , Sobel JD , Rompalo AM , Cu-Uvin S , Schoenbaum E , Jamieson DJ . Sex Transm Dis 2011 38 (10) 909-12 An analysis of data from a prospective study of 1257 high-risk women revealed 7 predictors of discordance between self-reported lack of recent exposure to semen and detection of spermatozoa on Gram stain, suggesting that inaccuracies in the reporting of sexual behaviors cannot be assumed to be distributed randomly. |
Combination contraceptives: effects on weight
Gallo MF , Lopez LM , Grimes DA , Schulz KF , Helmerhorst FM . Cochrane Database Syst Rev 2011 9 (9) CD003987 BACKGROUND: Weight gain is often considered a side effect of combination hormonal contraceptives, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. However, a causal relationship between combination contraceptives and weight gain has not been established. OBJECTIVES: The aim of the review was to evaluate the potential association between combination contraceptive use and changes in weight. SEARCH STRATEGY: We searched the computerized databases CENTRAL (The Cochrane Library), MEDLINE, POPLINE, EMBASE, and LILACS for studies of combination contraceptives, as well as ClinicalTrials.gov and International Clinical Trials Registry Platform (ICTRP). Searches were conducted from January to May 2011. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search. SELECTION CRITERIA: All English-language, randomized controlled trials were eligible if they had at least three treatment cycles and compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, or study length. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan. A second author verified the data entered. For continuous data, we calculated the mean difference and 95% confidence interval (CI) for the mean change in weight between baseline and post-treatment measurements using a fixed-effect model. For categorical data, such as the proportion of women who gained or lost more than a specified amount of weight, the Peto odds ratio with 95% CI was calculated. MAIN RESULTS: We found 49 trials that met our inclusion criteria. The trials included 85 weight change comparisons for 52 distinct contraceptive pairs (or placebos). The four trials with a placebo or no intervention group did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight change. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight change did not differ between groups where this was studied. AUTHORS' CONCLUSIONS: Available evidence was insufficient to determine the effect of combination contraceptives on weight, but no large effect was evident. Trials to evaluate the link between combination contraceptives and weight change require a placebo or non-hormonal group to control for other factors, including changes in weight over time. |
Do women using long-acting reversible contraception reduce condom use? A novel study design incorporating semen biomarkers
Gallo MF , Warner L , Jamieson DJ , Steiner MJ . Infect Dis Obstet Gynecol 2011 2011 107140 Long-acting reversible contraceptive (LARC) methods are highly effective against pregnancy. A barrier to their widespread promotion can include the concern they will lead reduced condom use and, thus, will put couples at higher risk for sexually transmitted infections (STIs). We review evidence from previous studies of condom "migration" associated with the use of LARC and propose a novel study design to address the two main methodological issues that have limited these earlier studies. Namely, we propose to use a randomized controlled trial design and to use a biological marker of semen exposure for measuring changes in condom use. |
Determinants of condom use among female sex workers in Kenya: a case-crossover analysis
Gallo MF , Warner L , Bell AJ , Bukusi EA , Sharma A , Njoroge B , Ngugi E , Jamieson DJ , Eschenbach DA . J Womens Health (Larchmt) 2011 20 (5) 733-8 BACKGROUND: We evaluated predictors of consistent condom use among female sex workers (FSWs), a core group for controlling the spread of HIV. METHODS: In an analysis of data collected in 2004-2005 from 140 Kenyan FSWs who completed questionnaires administered during a baseline study visit and three bimonthly follow-up visits, we used a case-crossover design to identify predictors of consistent condom use during all coital acts in the preceding 2 weeks, overall and by partner type. RESULTS: Participants (n=140) completed the baseline visit and 390 bimonthly follow-up visits. Alcohol use during sex was negatively associated with consistent condom use with helping partners (defined as regular sex partners to whom the woman could go for help or support if needed) (adjusted odds ratio [AOR], 2.6, 95% confidence interval [CI] 1.0-6.5) but not associated with condom use with other partners. Coital frequency was associated with condom use with other partners only. Women who reported 1-5 (AOR 11.0, 95% CI 4.3-28.3) or 6-9 recent coital acts (AOR 3.8, 95% CI 1.7-8.8) with other partners were more likely to report consistent condom use with those partners than were women who reported ≥10 acts. Having a recent partner delay payment was inversely associated with consistent condom use with helping, other, or all partners. CONCLUSIONS: Correlates of consistent condom use differed by partner type. By using a case-crossover design, we were able to identify potentially modifiable factors associated with consistent condom use by FSWs who used condoms consistently with a given partner type during some periods but not others. |
Assessing male condom failure and incorrect use
Duerr A , Gallo MF , Warner L , Jamieson DJ , Kulczycki A , Macaluso M . Sex Transm Dis 2011 38 (7) 580-6 BACKGROUND: It has not been well established whether common indices of male condom failure are valid predictors of biologically meaningful exposure during condom use. METHODS: To address this gap, the authors compared self-reported condom malfunctions (i.e., breakage and slippage) and incorrect condom practices to 2 following objective measures of failure: prostate-specific antigen (PSA) detected in vaginal swabs collected after condom use and structural integrity of used condoms. The study, conducted in 2000-2001, evaluated 635 male condoms used by 77 women attending an outpatient, reproductive-health clinic in Birmingham, AL. RESULTS: Women reported breakage or slippage for 7.9% of condoms; 3.5% of postcoital swabs had moderate or high levels of PSA; and laboratory testing of used condoms revealed breaks (1.1%) and leaks (2.0%). Self-reported breakage and slippage was associated with moderate/high PSA concentrations in postcoital swabs only when the malfunctions were not accompanied by reports of corrective actions to reduce exposure (adjusted odds ratio [aOR], 6.9; 95% confidence interval [CI], 1.8-26.2). Defects observed in postcoital laboratory testing were related to PSA detection (aOR, 8.0; 95% CI, 1.5-42.6). Incorrect practices defined on the condom label were frequent, but not all types were associated with semen exposure. Furthermore, other practices not currently label-defined were associated with semen exposure: touching the tip of the penis with his hands (aOR, 6.2; 95% CI, 2.3-17.0) or with her hands (aOR, 2.8; 95% CI, 1.1-72) before donning the condom. CONCLUSIONS: Used correctly, male condoms afforded good protection based on objective measures of failure. |
20 µg versus >20 µg estrogen combined oral contraceptives for contraception
Gallo MF , Nanda K , Grimes DA , Lopez LM , Schulz KF . Cochrane Database Syst Rev 2011 1 (1) CD003989 BACKGROUND: Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). However, reducing the amount of estrogen to improve safety could result in decreased contraceptive effectiveness and unacceptable changes in bleeding patterns. OBJECTIVES: To test the hypothesis that COCs containing ≤ 20 mug ethinyl estradiol (EE) perform similarly as those containing > 20 mug in terms of contraceptive effectiveness, bleeding patterns, discontinuation, and side effects. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov, and ICTRP, and examined references of eligible trials. Initially, we wrote to oral contraceptive manufacturers to identify trials. SELECTION CRITERIA: English-language reports of randomized controlled trials were eligible that compare a COC containing ≤ 20 mug EE with a COC containing > 20 mug EE. We excluded studies where the interventions were designed to be administered for less than three consecutive cycles or to be used primarily as treatment for non-contraceptive conditions. Trials had to report on contraceptive effectiveness, bleeding patterns, trial discontinuation due to bleeding-related reasons or other side effects, or side effects to be included in the review. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from literature searches to determine whether they met the inclusion criteria. Two authors independently extracted data from studies identified for inclusion. We wrote to the researchers when additional information was needed. Data were entered and analyzed with RevMan. MAIN RESULTS: No differences were found in contraceptive effectiveness for the 13 COC pairs for which this outcome was reported. Compared to the higher-estrogen pills, several COCs containing 20 mug EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea or infrequent bleeding and irregular, prolonged, frequent bleeding, or breakthrough bleeding or spotting). AUTHORS' CONCLUSIONS: While COCs containing 20 mug EE may be theoretically safer, this review did not focus on the rare events required to assess this hypothesis. Data from existing randomized controlled trials are inadequate to detect possible differences in contraceptive effectiveness. Low-dose estrogen COCs resulted in higher rates of bleeding pattern disruptions. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose. Higher follow-up rates are essential for meaningful interpretation of results. |
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