Young Black women in the southern US face a high HIV burden. While daily oral HIV pre-exposure prophylaxis (PrEP) can effectively prevent HIV, its use is low among Black women. The acceptability of and perceived intention to use emerging PrEP products among young Black women in the southern US are not well understood. Non-oral PrEP alternatives could address challenges to PrEP uptake and reduce health disparities. We conducted virtual semi-structured interviews with Black women aged 18-34 in Atlanta, GA; Baton Rouge, LA; and Jackson, MS, to explore their perspectives on three emerging PrEP products: a long-acting injection, a subdermal implant, and a dual-purpose contraception and HIV prevention intravaginal ring. Seventy-five interviews were conducted from January to October 2021 and analyzed using inductive thematic analysis with NVivo software. Most participants were open to using medication to prevent HIV. The intravaginal ring was the most preferred, primarily due to its dual-purpose function, although it was also frequently rejected. The long-acting injection was the second most preferred and least rejected, perceived as the least invasive. The skin implant was the least preferred and most rejected, viewed as the most invasive. Our findings highlight the need for multiple PrEP options to meet individual preferences. Detailed descriptions, instructions, and experiential learning methods are crucial for choosing non-oral PrEP modalities. Practitioners should address questions and offer peer-based learning opportunities. Designing and promoting PrEP strategies for young Black women should involve close consultation with these consumers.

INTRODUCTION: Globally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies. METHODS: Healthy women ages 18-34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition. RESULTS: Among 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36-90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and -27.1% to -20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively). CONCLUSION: TFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. CLINICAL TRIAL REGISTRATION: NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382].

BACKGROUND: Given future potential use of vaginal rings to prevent HIV infection, we examined the association of contraceptive vaginal ring (CVR) non-adherence with user dissatisfaction, tolerability, demographic, and behavioral factors. METHODS: In an open-label single-group study, sexually active women aged 18-34 years using oral or injectable hormonal contraception, conveniently sampled from general population, were assigned to 6-month use of a commercial CVR currently not licensed for use in Kenya. Non-adherence in any CVR cycle completed was assessed from: (1) self-report (not used for at least 1 day), and (2) pharmacy record (failure to timely receive a new CVR or return a used one). Additionally, non-adherence was assessed in a subset of participants by residual progestin and estrogen levels measured in returned CVRs. RESULTS: Of 202 participants who underwent CVR insertion by a study clinician, 142 completed all 6 visits, 172 responded to questions about ring use, and 43 provided used CVRs from months 1, 3, and 6 for residual hormone analysis. Non-adherence was 14.0% (24/172) by self-report and 54.5% (110/202) by pharmacy record. Non-adherence by pharmacy record was significantly reduced among women with a salary-based income (prevalence ratio (PR) 0.71, 95% confidence interval (CI) (0.55-0.91)] compared to women with income not salary-based or no income. Participants dissatisfied with CVR on ≥4 aspects (ambiguity of instructions, inconvenience of use, sensation, sexual discomfort, etc.) were more likely to report non-adherence (PR 2.69, 95% CI=(1.31-5.52)] compared to those dissatisfied with ≤3 aspects. Non-adherence by residual hormone levels was identified in 46.5% (20/43) participants. Over time, this subset of participants showed increasing non-adherence (P=0.004). We found lack of agreement among the various measures of non-adherence. CONCLUSIONS: Economic empowerment interventions, especially those emphasizing partner-independent income options, and expanded education on CVR features may alleviate non-adherence. Addressing CVR dissatisfaction preemptively may also help mitigate non-adherence.

Multipurpose prevention technology intravaginal rings (MPT IVRs) may offer a promising solution for addressing multiple women's sexual and reproductive health needs. We describe MPT IVR acceptability perspectives and examine user experiences of 25 cisgender women aged 18-3years enrolled in a phase IIa randomized, partially blinded, placebo-controlled evaluation of tenofovir-based IVRs with and without contraceptive co-formulation. All took part in an individual, audio-recorded, semi-structured qualitative interview. A thematic analysis of transcribed interviews was completed in MaxQDA. Participants shared little or no knowledge of or experience with IVRs prior to joining the study. Four MPT IVR themes were identified: physical wellbeing, method reliability, personal management, and societal endorsement. Commonly cited of concern, but less described as being experienced, were physical discomforts (e.g., painful insertion/removal; inability to carry out daily activities/chores; foreign body sensation; expulsion; sexual interference, or debilitating side effects). Uncertainty regarding efficacy influenced perspectives about intended prevention benefits. Personal choices in managing reproduction and sexual behaviors had to be congruent with sociocultural values and norms for acceptance beyond the individual user level. Participants viewed broader community acceptance as likely to be mixed given community opposition to the use of modern family planning methods. They also shared concerns that IVR use could lead to infertility, especially among nulliparous women, or that it would encourage premarital sex or high-risk sexual behaviors among adolescent and young women. While a MPT IVR may not be suitable for all women, first-hand testimonials could help influence collective receptivity. Additional community acceptability research is needed. Clinical Trial Registration The study is registered at ClinicalTrials.gov under the identifier NCT03762382.

In a phase-IIa trial, we investigated the influence of 90 days continuous-delivery tenofovir (TFV) intravaginal rings (IVRs) with/without levonorgestrel (LNG) on the genital microbiota of Kenyan women. Eligible women (n = 27; 18-34 years; negative for HIV, sexually transmitted infections, and Amsel-bacterial vaginosis) were randomized 2:2:1 to use of IVRs containing TFV, TFV/LNG, or placebo. Using vaginal wall and IVR swabs at IVR insertion and removal, the genital microbial composition was determined using 16S rRNA gene sequencing. The presence of Candida spp. was determined using qPCR. The vaginal total bacterial burden appeared to decrease with TFV and TFV/LNG IVR use (log(10)0.57 and log(10)0.27 decrease respectively; p > 0.05). The TFV/LNG IVR was more 'stabilizing': 50% of the participants' microbiota community state types remained unchanged and 50% shifted towards higher Lactobacillus abundance. Specifically, TFV/LNG IVR use was accompanied by increased abundances of Lactobacillus gasseri/hominis/johnsonii/taiwanensis (16.3-fold) and L. fermentum/reuteri/vaginalis (7.0-fold; all p < 0.01). A significant shift in the overall microbial α-diversity or β-diversity was not observed for either IVR, and IVR use did not influence Candida spp. prevalence. TFV/LNG and TFV IVRs did not adversely affect the genital microbiota and are safe to use. Our findings support further studies assessing their efficacy in preventing HIV/HSV-2 and unintended pregnancies.

Sex at an early age can have later life negative health outcomes. Insights on early sexual activity may help in the development of future health-promotion products and interventions related to pregnancy and sexually transmitted infections (STIs) prevention. Among Kenyan women participating in a contraceptive vaginal ring study, we determined: (1) the proportion with first sex at 15 years (early sex) and (2) factors associated with early sex. Baseline data collection and testing for pregnancy, STIs, and HIV were undertaken. A log-binomial or a modified Poisson regression was used to estimate univariable prevalence ratios and multivariable adjusted prevalence ratios (aPRs). Among 332 women aged 18-34 years, the median age of first sex was 16 years, with 40.1% experiencing early sex. Overall, 29.8% reported an older first sex partner (5 years); 83.9% indicated lack of readiness or intentions at first sex; and 56.2% received money, gifts, or favors as part of first sex. Early sex was more prevalent among inherited widows (a Luo cultural practice, aPR 1.49), gift recipients (aPR 1.38), women with a forced/unwanted sex history (aPR 1.42), or those with a partner of unknown or positive HIV status in the past 3 months (aPR 1.45). Sex before or at the age 15 may be associated with higher sexual risk behaviors. Complex power and gender relations may additionally influence exposure to sexual risk in our research setting.

We assessed prevalence and correlates of bacterial vaginosis (BV) and sexually transmitted infections (STIs) including herpes simplex virus type 2 (HSV-2), gonorrhoea (GC), syphilis (SYP), Chlamydia (CT) and HIV among Kenyan women aged 18-34 years who were screened for a contraceptive intravaginal ring study. Women provided demographic, behavioural and medical information, and underwent medical evaluation, including a pelvic exam. We computed crude and adjusted prevalence ratio (aPR) and 95% confidence interval (CI) using log-binomial regression. Of 463 women screened, 457 provided laboratory specimens and were included in the analysis. The median age was 25 years, interquartile range (21-28), and 68.5% had completed primary or lower education. Overall, 72.2% tested positive for any STI or BV. Point prevalence was 55.6, 38.5, 3.9, 2.0, 4.6, and 14.7% for HSV-2, BV, GC, SYP, CT, and HIV, respectively. Co-infection with HSV-2, BV, and HIV occurred in 28 (6.1%) participants. Having >/=1 STI/BV was associated with younger age at first sex (</=13 versus 17-19 years, aPR=1.27, 95% CI 1.07-1.51), history of exchange sex (aPR = 2.05, 95% CI 1.07-3.92), sexual intercourse in the past seven days (aPR = 1.17, 95% CI 1.01-1.36), and older age (30-34 versus 18-24 years, aPR = 1.26, 95% CI 1.06-1.48). STI/BV diagnosis was less likely for women reporting one lifetime sexual partner compared to women with >/=4 lifetime sexual partners (aPR = 0.70, 95% CI 0.54-0.92). Combination prevention approaches (biomedical, behavioural, social, and structural) tailored to women with diverse risk profiles may help mitigate STI/BV prevalence in this setting.

BACKGROUND: Future HIV prevention options for women will likely include Antiretroviral (ARV)-based intravaginal rings. Valuable insights may be gained by examining user experiences with a similar licensed technology, a contraceptive ring, especially in settings where this technology may not be currently available. METHODS: In-depth interviews with 24 females enrolled in a trial assessing acceptability and use of a contraceptive ring, and 20 male sexual partners were conducted September 2014-April 2015. Elements of ethnography and phenomenological anthropology were used to collect, analyze, interpret, and describe ring users' experiences. Thematic analysis was completed in MaxQDA-10. RESULTS: Experiences with the contraceptive ring reflected a broader Family Planning (FP) paradigm that centered around three themes: latitudes and drawbacks of FP (being free); an FP method needs to be compatible with a woman's body (feeling normal); and dealing with fertility control uncertainties (how well does it really work). FP intentions and disclosure practices were influenced by partner support, socioeconomic factors, religion, cultural beliefs, and societal norms, including female sexuality. A user-friendly FP design was emphasized. Non-suppression of menstruation was favored by most. Unease with vaginal insertion as well as ring placement issues (slippage, expulsion) created initial challenges requiring clinician assistance and practice for some participants. While minor side-effects were described, concerns centered on ring efficacy, negative effect on a woman's sexual desire, and future fertility issues. CONCLUSIONS: Awareness of the multiple contexts in ring users' experience may inform the development, education, and promotion approaches for future ARV rings.

BACKGROUND: Attention to mental health issues is growing globally. In many countries, including Kenya, however, assessment of psychological distress, especially in rural areas, is limited. METHODS: We analyzed data from young women screened for a longitudinal contraceptive ring study in Kisumu, Kenya. Multivariable regression analysis was used to assess factors associated with recent moderate and high psychological distress, as measured by the Kessler (K-6) psychological distress scale. RESULTS: Among the 461 women screened, most (58.4%) were categorized as having moderate psychological distress, 20.8% were categorized as having low or no psychological distress, and 20.8% were categorized as having high psychological distress. Moderate psychological distress (vs low/no) was significantly more likely among women who reported a history of forced sex and were concerned about recent food insecurity. High (vs low/no) psychological distress was significantly more likely among women who reported a history of forced sex, who were concerned about recent food insecurity, and who self-reported a sexually transmitted infection. CONCLUSION: To reduce psychological distress, a focus on prevention as well as care methods is needed. Girls need a path toward a healthy and productive adulthood with a focus on education, which would help them gain skills to avoid forced sex. Women would benefit from easy access to social services and supports that would help them with basic needs like food security among other things. A holistic or ecological approach to services that would address mental, educational, social, health, and economic issues may have the highest chance of having a long-term positive impact on public health.

OBJECTIVE: This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials. STUDY DESIGN: Residual etonogestrel and ethinyl estradiol levels from used NuvaRings(R) of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing(R) as their contraceptive choice. RESULTS: Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones. CONCLUSION: Residual vaginal ring drug levels could help assess adherence in clinical trials.

BACKGROUND: HIV antiretroviral-based intravaginal rings with and without co-formulated contraception hold promise for increasing HIV prevention options for women. Acceptance of and ability to correctly and consistently use this technology may create challenges for future ring-based microbicide trials in settings where this technology has not been introduced. We examined baseline factors associated with enrolling in a contraceptive intravaginal ring study in Kisumu, Kenya and describe notional acceptability (willingness to switch to a contraceptive ring based solely on information received about it). METHODS: Demographic, psychosocial, and behavioral eligibility screening of women 18-34 years was undertaken. Testing for pregnancy, HIV, and other sexually transmitted infections (STIs) was also conducted. We compared enrollment status across groups of categorical predictors using prevalence ratios (PR) and 95% confidence interval (CI) estimates obtained from a log-binomial regression model. RESULTS: Out of 692 women pre-screened April to November 2014, 463 completed screening, and 302 women were enrolled. Approximately 97% of pre-screened women were willing to switch from their current contraceptive method to use the intravaginal ring exclusively for the 6-month intervention period. Pregnancy, HIV, and STI prevalence were 1.7%, 14.5%, and 70.4% respectively for the 463 women screened. Women 18-24 (PR=1.47, CI 1.15-1.88) were more likely to be enrolled than those 30-34 years of age, as were married/cohabitating women (PR=1.62, CI 1.22-2.16) compared to those separated, divorced, or widowed. In adjusted analyses, sexual debut at less than 17 years of age, one lifetime sexual partner, abnormal vaginal bleeding in the past 12 months, condomless vaginal or anal sex in the past 3 months, and not having a sexual partner of unknown HIV status in the past 3 months were predictive of enrollment. CONCLUSION: High notional acceptability suggests feasibility for contraceptive intravaginal ring use. Factors associated with ring use initiation and 6-month use will need to be assessed.

Heterosexual anal intercourse is associated with increased risk for HIV and other sexually transmitted infections. Research on the social and psychological risk factors associated with heterosexual unprotected anal intercourse among Hispanic women in the USA is limited. We examined demographic, mental health, relationship power, sexual self-efficacy, self-esteem, acculturation and HIV knowledge as correlates of unprotected anal intercourse among 514 HIV-negative Hispanic women, 18 to 59 years of age, residing in one urban county in southern Florida. In both unadjusted and adjusted results, the likelihood of engaging in unprotected anal intercourse was associated with food insecurity in the past 30 days (adjusted odds ratio [AOR] = 1.57, 95% confidence interval [CI] 1.03, 2.40) and more interpersonal power attributed to the male partner (AOR = 1.63, 95%CI 1.08, 2.45). Not significant, yet of possible importance, were ever having engaged in exchange sex (AOR = 1.96, 95%CI = 0.97, 3.98) and lower HIV knowledge (AOR = 0.80, 95%CI = 0.63, 1.01). Interventions aimed at reducing heterosexual unprotected anal intercourse risk for HIV infection among Hispanic women may benefit by addressing socioeconomic and interpersonal issues, and assessing HIV knowledge and comprehension.

Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.

INTRODUCTION: While relatively rare events, abrupt disruptions in heroin availability have a significant impact on morbidity and mortality risk among those who are heroin dependent. A heroin shortage occurred in Coast Province, Kenya from December 2010 to March 2011. This qualitative analysis describes the shortage events and consequences from the perspective of heroin users, along with implications for health and other public sectors. METHODS: As part of a rapid assessment, 66 key informant interviews and 15 focus groups among heroin users in Coast Province, Kenya were conducted. A qualitative thematic analysis was undertaken in Atlas.ti. to identify salient themes related to the shortage. RESULTS: Overall, participant accounts were rooted in a theme of desperation and uncertainty, with emphasis on six sub-themes: (1) withdrawal and strategies for alleviating withdrawal, including use of medical intervention and other detoxification attempts; (2) challenges of dealing with unpredictable drug availability, cost, and purity; (3) changes in drug use patterns, and actions taken to procure heroin and other drugs; (4) modifications in drug user relationship dynamics and networks, including introduction of risky group-level injection practices; (5) family and community response; and (6) new challenges with the heroin market resurgence. CONCLUSIONS: The heroin shortage led to a series of consequences for drug users, including increased risk of morbidity, mortality and disenfranchisement at social and structural levels. Availability of evidence-based services for drug users and emergency preparedness plans could have mitigated this impact.

BACKGROUND: To the individual with concurrent partners, it is thought that having concurrent partnerships confers no greater risk of acquiring HIV than having multiple consecutive partnerships. However, an individual whose partner has concurrent partnerships (partner's concurrency) is at increased risk for incident HIV infection. We sought to better understand relationships characterized by partner's concurrency among African American women. METHODS: A total of 1013 African American women participated in a cross-sectional survey from 4 rural Southeastern counties. RESULTS: Older age at first sex was associated with lower prevalence of partner's concurrency (prevalence ratio, 0.70; 95% confidence interval, 0.57-0.87), but the participant's age was not associated with partner's concurrency. After adjusting for covariates, ever having experienced intimate partner violence (IPV) and forced sex were most strongly associated with partner's concurrency (prevalence ratios, 1.61 [95% confidence intervals, 1.23-2.11] and 1.65 [1.20-2.26], respectively). Women in mutually monogamous partnerships were the most likely to receive economic support from their partners; women whose partners had concurrent partnerships did not report more economic benefit than did those whose partners were monogamous. CONCLUSIONS: Associations between history of IPV and forced sex with partner's concurrency suggest that women with these experiences may particularly benefit from interventions to reduce partner's concurrency in addition to support for reducing IPV and other sexual risks. To inform these interventions, further research to understand partnerships characterized by partner's concurrency is warranted.

OBJECTIVE: To identify factors associated with repeat pregnancy subsequent to an index pregnancy among women living with HIV (WLWH) in western Kenya who were enrolled in a 24-month phase-II clinical trial of triple-ART prophylaxis for prevention of mother-to-child transmission, and to contextualize social and cultural influences on WLWH's reproductive decision making. METHODS: A mixed-methods approach was used to examine repeat pregnancy within a 24 month period after birth. Counselor-administered questionnaires were collected from 500 WLWH. Forty women (22 with a repeat pregnancy; 18 with no repeat pregnancy) were purposively selected for a qualitative interview (QI). Simple and multiple logistic regression analyses were performed for quantitative data. Thematic coding and saliency analysis were undertaken for qualitative data. RESULTS: Eighty-eight (17.6%) women had a repeat pregnancy. Median maternal age was 23 years (range 15-43 years) and median gestational age at enrollment was 34 weeks. In multiple logistic regression analyses, living in the same compound with a husband (adjusted odds ratio (AOR): 2.33; 95% confidence interval (CI): 1.14, 4.75) was associated with increased odds of repeat pregnancy (p ≤ 0.05). Being in the 30-43 age group (AOR: 0.25; 95% CI: 0.07, 0.87), having talked to a partner about family planning (FP) use (AOR: 0.53; 95% CI: 0.29, 0.98), and prior usage of FP (AOR: 0.45; 95% CI: 0.25, 0.82) were associated with a decrease in odds of repeat pregnancy. QI findings centered on concerns about modern contraception methods (side effects and views that they 'ruined the womb') and a desire to have the right number of children. Religious leaders, family, and the broader community were viewed as reinforcing cultural expectations for married women to have children. Repeat pregnancy was commonly attributed to contraception failure or to lack of knowledge about post-delivery fertility. CONCLUSIONS: In addition to cultural context, reproductive health programs for WLWH may need to address issues related to living circumstances and the possibility that reproductive-decision making may extend beyond the woman and her partner.

Communicating findings to study participants and their communities is a practice that often gets overlooked or receives low prioritization by research investigators, but is crucially important. The purpose of this study was to describe the process and community response to the dissemination of results from the Kisumu Breastfeeding Study (KiBS), specifically in terms of (1) community research knowledge and expectations and (2) impressions of result dissemination efforts. A qualitative evaluation was completed for 10 result dissemination events using focus group discussions (FGDs) (n = 10; total number of participants = 98). An inductive, thematic qualitative data analysis was completed in NVivo 8.0. Overall, FGD participants expressed great appreciation for being given information on the study results. Participants had a good understanding of what research entails and had specific expectations for the process, including that the community receive information about the study, not only at the end of the study but also at regular intervals throughout the study's conduct. They also wanted to receive the communications from a credible source, the principal investigator preferably. Other expectations centered on better community and research interactions and development and the use of community collaborators. Impressions of KiBS result dissemination events were positive, but suggestions for the future included having the event in a larger area, inviting more people, having more written materials, and putting the information in an entertaining format such as skits or movies. Sharing study findings with local community members is essential and beneficial to the researchers' long-term engagement with communities and importantly, the successful implementation of study findings when appropriate. It is imperative that dissemination of results be embedded as an integral part of research project planning and development.

OBJECTIVES: This cross-sectional study examined African American and Hispanic women's (N = 1,509) self-reports of unwanted forced sex and its association with behavioral and mental health outcomes after the event. METHODS: Twenty percent of the women had experienced forced sex (1st occurrence at age 15 years or younger for 10%, 1st occurrence at older than 15 years of age for 10%). RESULTS: Regardless of when forced sex 1st occurred, women were more likely to have engaged in unprotected vaginal and anal sex, to have had multiple unprotected sex partners, to have sexually transmitted infections, to have reported binge drinking and illicit drug use, and to exhibit distress and have received mental health counseling. CONCLUSIONS: Forced sex may have wide-ranging behavioral and mental health consequences years later.

In a cross-sectional survey of 1,013 African American women from rural Alabama and North Carolina, we examined the relationship of (1) organizational religiosity (i.e., religious service attendance), (2) non-organizational religiosity (e.g., reading religious materials), and (3) spirituality with these outcomes: women's reports of their sexual behaviors and perceptions of their partners' risk characteristics. Women with high non-organizational religiosity, compared with low, had fewer sex partners in the past 12 months (adjusted prevalence ratio (aPR): 0.58, 95% confidence interval (CI): 0.42, 0.80) and were less likely to have concurrent partnerships (aPR: 0.47, 95% CI: 0.30, 0.73). Similar results were observed for spirituality, and protective but weaker associations were observed for organizational religiosity. Weak associations were observed between organizational religiosity, non-organizational religiosity, and spirituality with partners' risk characteristics. Further exploration of how religiosity and spirituality are associated with protective sexual behaviors is needed to promote safe sex for African American women.

We estimated HIV prevalence and identified correlates of HIV infection among 1106 men and women aged 16-34 years residing in Kisumu, Kenya. Demographic, sexual, and other behavioural data were collected using audio computer-assisted self-interview in conjunction with a medical examination, real-time parallel rapid HIV testing, and laboratory testing for pregnancy, gonorrhoea, chlamydia, syphilis, and herpes simplex virus type 2. Multivariate logistic regression was used to identify variables associated with prevalent HIV infection by gender. Overall HIV prevalence was 12.1%. HIV prevalence among women (17.1%) was approximately two and one half times the prevalence among men (6.6%). Odds of HIV infection in men increased with age (aOR associated with one year increase in age = 1.21, CI = 1.07-1.35) and were greater among those who were uncircumcised (aOR = 4.42, CI = 1.41-13.89) and those who had an herpes simplex virus type 2 positive (aOR = 3.13, CI = 1.12-8.73) test result. Odds of prevalent HIV infection among women also increased with age (aOR associated with one year increase in age = 1.16, CI = 1.04-1.29). Women who tested herpes simplex virus type 2 positive had more than three times the odds (aOR = 3.85, CI = 1.38-10.46) of prevalent HIV infection compared with those who tested herpes simplex virus type 2 negative. Tailored sexual health interventions and programs may help mitigate HIV age and gender disparities.

This study examined study product adherence and its determinants in the Botswana oral pre-exposure prophylaxis efficacy trial. Among the 1,219 participants, the mean adherence by pill count and 3-day self-report was 94 % for each. In multivariable models, pill count adherence was significantly associated with adverse events (nausea, dizziness, vomiting) (RR 0.98 95 % CI 0.98-1.00; p = 0.03) and side effect concerns (RR 0.98 95 % CI 0.96-0.99; p = 0.01). Self-reported adherence was significantly associated with having an HIV-positive partner (RR 1.02 95 % CI 1.00-1.04; p = 0.02) and Francistown residence (RR 0.98 95 % CI 0.96, 0.99; p = 0.0001). Detectable drug concentrations showed modest associations with self-report and pill count adherence, and drug levels were higher among those self-reporting 100 % adherence than those reporting <100 %. Most common adherence barriers involved refill delays and other logistic challenges; cellphone alarm reminder use was the most common facilitator.

BACKGROUND: We determined the prevalence of four sexually transmitted infections and the demographic and behavioural correlates associated with having one or more sexually transmitted infections among participants in an HIV incidence cohort study in Kisumu, western Kenya. METHODS: Participants were enrolled from a convenience sample and underwent aetiologic sexually transmitted infection investigation. Demographic and behavioural information were collected and basic clinical evaluation performed. Multiple regression analysis was done to determine variables associated with having one or more sexually transmitted infections. RESULTS: We screened 846, 18- to 34-year-olds. One-third had at least one sexually transmitted infection with specific prevalence being, syphilis; 1.6%, gonorrhoea; 2.4%, herpes simplex virus type-2; 29.1%, chlamydia; 2.8%, and HIV; 14.8%. Odds of having any sexually transmitted infection were higher among participants who were women, were aged 20-24 or 30-34 years compared to 18-19 years, had secondary or lower education compared to tertiary education, were divorced, widowed or separated compared to singles, reported having unprotected sex compared to those who did not, reported previous sexually transmitted infection treatment, and tested HIV-positive. CONCLUSION: Multiple strategies are needed to address the overall high prevalence of sexually transmitted infections as well as the gender disparity found in this Kenyan population. Structural interventions may be beneficial in addressing educational and socio-economic barriers, and increasing the uptake of health-promoting practices.

HIV risk perceptions and behaviors of 236 commercial sex workers from three major Mozambican urban centers were studied using the International Rapid Assessment, Response and Evaluation (I-RARE) methodology. All were offered HIV testing and, in Maputo, syphilis testing was offered as well. Sixty-three of the 236 opted for HIV testing, with 30 (48%) testing positive for HIV. In Maputo, all 30 receiving HIV tests also had syphilis testing, with 6 (20%) found to be positive. Results include interview excerpts and qualitative results using I-RARE methodology and AnSWR-assisted analyses of the interviews and focus group sessions.

BACKGROUND: While laboratory aetiological diagnosis is considered the gold standard for diagnosis and management of sexually transmitted infections, syndromic management has been presented as a simplified and affordable approach for sexually transmitted infection management in limited resource settings. METHODS: Sexually transmitted infection signs and symptoms were collected using staff-administered computer-assisted personal interview and audio computer-assisted self-interview. Participants underwent a medical examination and laboratory testing for common sexually transmitted infections. The performance of syndromic management was assessed on the agreement between interviewing methods as well as accurate diagnosis. RESULTS: We screened 846 participants, of whom 88 (10.4%) received syndromic sexually transmitted infection diagnosis while 272 (32.2%) received an aetiological diagnosis. Agreement between syndromic and aetiological diagnoses was very poor (overall kappa = 0.09). The most prevalent sexually transmitted infection was herpes simplex virus type 2 and the percentage of persons with any sexually transmitted infection was higher among women (48.6%) than men (15.6%, p < 0.0001). Agreement between audio computer-assisted self-interview and computer-assisted personal interview interviewing methods for syndromic diagnosis of sexually transmitted infections ranged from poor to good. CONCLUSION: Our findings suggest that syndromic management of sexually transmitted infections is not a sufficient tool for sexually transmitted infection diagnosis in this setting; development and improvement of sexually transmitted infection diagnostic capabilities through laboratory confirmation is needed in resource-limited settings.

Cost-effective HIV prevention programs should target persons at high risk of HIV acquisition. We conducted an observational HIV incidence cohort study in Kisumu, Kenya, where HIV prevalence is triple that of the national rate. We used referral and venue-sampling approaches to enroll HIV-negative persons for a 12-month observational cohort, August 2010 to September 2011, collected data using computer-assisted interviews, and performed HIV testing quarterly. Among 1292 eligible persons, 648 (50%) were excluded for HIV positivity and other reasons. Of the 644 enrollees, 52% were women who were significantly older than men (P < .01). In all, 7 persons seroconverted (incidence rate [IR] per 100 person-years = 1.11; 95% confidence interval [CI] 0.45-2.30), 6 were women; 5 (IR = 3.14; 95% CI 1.02-7.34) of whom were ≤25 years. Most new infections occurred in young women, an observation consistent with other findings in sub-Saharan Africa that women aged ≤25 years are an important population for HIV intervention trials in Africa.

BACKGROUND: HIV prevention efforts have given limited attention to the relational schemas and scripts of adult heterosexual women. These broader schemas and scripts of romantic and other sexual liaisons, partner selection, relationship dynamics, and power negotiations may help to better understand facilitators and barriers to HIV risk-reduction practices. METHODS: We conducted exploratory qualitative interviews with 60 HIV-uninfected heterosexual African-American women from rural counties in North Carolina and Alabama, and Hispanic women from an urban county in southern Florida. Data were collected for relationship expectations; relationship experiences, and relationship power and decision-making. Interview transcripts underwent computer-assisted thematic analysis. RESULTS: Participants had a median age of 34 years (range 18--59), 34% were married or living as married, 39% earned an annual income of $12,000 or less, 12% held less than a high school education, and 54% were employed. Among the Hispanic women, 95% were foreign born. We identified two overarching relationship themes: contradictions between relationship expectations and desires and life circumstances that negated such ideals, and relationship challenges. Within the contradictions theme, we discovered six subthemes: a good man is hard to find; sex can be currency used to secure desired outcomes; compromises and allowances for cheating, irresponsible, and disrespectful behavior; redefining dating; sex just happens; needing relationship validation. The challenges theme centered on two subthemes: uncertainties and miscommunication, and relationship power negotiation. Gender differences in relationship intentions and desires as well as communication styles, the importance of emotional and financial support, and the potential for relationships to provide disappointment were present in all subthemes. In examining HIV risk perceptions, participants largely held that risk for HIV-infection and the need to take precautions were problems of women who differed from them (i.e., abuse drugs, are promiscuous, exchange sex). CONCLUSION: Underlying women's relational schemas was a belief that relationship priorities differed for men and women. Consequently, expectations and allowances for partner infidelity and negligent behaviors were incorporated into their scripts. Moreover, scripts endorsed women's use of sex as currency in relationship formation and endurance, and did not emphasize HIV risk. Both couple- and gender-specific group-level interventions are needed to deconstruct (breakdown) and reconstruct (rewrite) relationship scripts.

INTRODUCTION: In an analysis of baseline findings of an HIV incidence cohort study, an assessment was made of HIV prevalence among persons presenting for enrollment and any differences in demographic characteristics between persons not enrolled compared to those enrolled. We also described and compared HIV risk behaviors in males and females enrolled in the study. METHODOLOGY: A computer-assisted survey was administered to collect baseline demographic and HIV risk data from 1,277 men and women aged 18-34 years. Testing for HIV and other sexually transmitted infections (STI) was conducted. Out of 1,277 persons prescreened for eligibility, 625 were enrolled. RESULTS: HIV prevalence of all persons who completed screening was 14.8% (females: 21.1%; males: 8.1%). The odds of being enrolled in the study were higher for persons 18-24 years compared to those 30-34 years of age [adjusted odds ratio (AOR)=2.18, CI=1.13, 4.21] and males compared to females [AOR=2.07, CI=1.43, 2.99]. Among those enrolled in the study, the most prevalent HIV risk behaviors were unprotected sex (49%), alcohol use (45%), and transactional sex (30%) in the last three months. Compared to females, a significantly greater proportion of males reported using any alcohol or recreational drug in the last three months, a history of oral sex, sex with partner other than a spouse or main partner, ever having a blood transfusion, ever being treated for an STI, and having knowledge of their last HIV test result. CONCLUSION: The Kisumu Field Station successfully recruited individuals with HIV risk characteristics for the HIV incidence cohort study.

BACKGROUND: During a period of evolving international consensus on how to engage communities in research, facilitators and barriers to participation in HIV prevention research were explored in a rural plantation community in the coastal region of Cameroon. METHODS: A formative rapid assessment using structured observations, focus group discussions (FGD), and key informant interviews (KIIs) was conducted with a purposive non-probabilistic sample of plantation workers and their household members. Eligibility criteria included living or working >1 year within the plantation community and age >18 years. Both rapid and in-depth techniques were used to complete thematic analysis. RESULTS: Sixty-five persons participated in the study (6 FGDs and 12 KIIs). Participants viewed malaria and gastrointestinal conditions as more common health concerns than HIV. They identified three factors as contributing to HIV risk: concurrent sexual relationships, sex work, and infrequent condom use. Interviewees perceived that the community would participate in HIV research if it is designed to: (1) improve community welfare, (2) provide comprehensive health services and treatment for illnesses, (3) protect the personal information of participants, especially those who test positive for HIV, (4) provide participant incentives, (5) incorporate community input, and (6) minimize disruptions to "everyday life". Barriers to participation included: (1) fear of HIV testing, (2) mistrust of researchers given possible disrespect or intolerance of plantation community life and lack of concern for communication, (3) time commitment demands, (3) medical care and treatment that would be difficult or costly to access, and (4) life disruptions along with potential requirements for changes in behaviour (i.e., engage in or abstain from alcohol use and sex activities). CONCLUSIONS: Consistent with UNAIDS guidelines for good participatory practice in HIV prevention research, study participants placed a high premium on researchers' politeness, trust, respect, communication, tolerance and empathy towards their community. Plantation community members viewed provision of comprehensive health services as an important community benefit likely to enhance HIV research participation.

A qualitative study examined perceptions of HIV testing and strategies to enhance HIV testing among HIV-negative African American heterosexual young adults (ages 18-25 years). Twenty-six focus groups (13 male groups, 13 female groups) were conducted in two low-income communities (urban and rural). All sessions were audio-recorded and transcribed. Data analysis was completed using AnSWR software. Many participants expressed that learning one's HIV status, regardless of the result, was a benefit of taking an HIV test because this was perceived to produce emotional relief. Additional benefits included the avoidance of unknowingly spreading the virus, being offered treatment access if HIV-positive, and taking time to assess and modify risky sexual behaviors if HIV-negative. If diagnosed HIV-positive, HIV testing concerns included the recognition of one's mortality, the experience of social stigma, and concerns about accessing affordable treatment. Recommended promotion strategies included the use of HIV-positive individuals, pop culture icons, and the media to promote HIV testing messages.

PURPOSE: We examined sexual risk behaviors and unrecognized HIV infection among heterosexually active African-American and Hispanic women. METHODS: Women not previously diagnosed with HIV infection were recruited in rural counties in North Carolina (African American) and Alabama (African American), and an urban county in southern Florida (Hispanic) using multiple methods. They completed a computer-administered questionnaire and were tested for HIV infection. RESULTS: Between October 2008 and September 2009, 1,527 women (1,013 African American and 514 Hispanic) enrolled in the study. Median age was 35 years (range, 18-59), 33% were married or living as married, 50% had an annual household income of $12,000 or less, and 56% were employed full or part time. Two women (0.13%) tested positive for HIV. In the past 12 months, 19% had been diagnosed with a sexually transmitted infection (other than HIV), 87% engaged in unprotected vaginal intercourse (UVI), and 26% engaged in unprotected anal intercourse (UAI). In multivariate analysis, UAI was significantly (p < .05) more likely among those who reported ever being pregnant, binge drinking in the past 30 days, ever exchanging sex for things needed or wanted, engaging in UVI, or being of Hispanic ethnicity. UAI was also more likely to occur with partners with whom women had a current or past relationship as opposed to casual partners. CONCLUSION: A high percentage of our sample of heterosexually active women of color had recently engaged in sexual risk behaviors, particularly UAI. More research is needed to elucidate the interpersonal dynamics that may promote this high-risk behavior. Educational messages that explicitly address the risks of heterosexual anal intercourse need to be developed for heterosexually active women and their male partners.