INTRODUCTION: Most gay, bisexual and other men who have sex with men (GBMSM) live in rights-constrained environments making retaining them in research to be as hard as recruiting them. To evaluate Anza Mapema, an HIV risk-reduction programme in Kisumu, Kenya, we examined the enrolment sociodemographic, behavioural, psychosocial and clinical factors associated with missing two or more follow-up visits for GBMSM participating in Anza Mapema. METHODS: Between August 2015 and November 2017, GBMSM were enrolled and followed in a prospective cohort study with quarterly visits over 12 months. At enrolment, men were tested for HIV and sexually transmitted infections and completed questionnaires via audio computer-assisted self-interview. Because the Kenya Ministry of Health recommends HIV testing every three to six months for GBMSM, the retention outcome in this cross sectional analysis was defined as missing two consecutive follow-up visits (vs. not missing two or more consecutive visits). Multivariable logistic regression estimated the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the associations of the enrolment characteristics with the binary outcome of retention. RESULTS AND DISCUSSION: Among 609 enrolled HIV-negative GBMSM, the median age was 23 years (interquartile range, 21 to 28 years), 19.0% had completed ≤8 years of education and 4.1% had resided in the study area <1 year at enrolment. After enrolment, 19.7% missed two consecutive follow-up visits. In the final multivariable model, the odds of missing two consecutive follow-up visits were higher for men who: resided in the study area <1 year at enrolment (aOR, 4.14; 95% CI: 1.77 to 9.68), were not living with a male sexual partner (aOR, 1.59; 95% CI: 1.01 to 2.50), and engaged in transactional sex during the last three months (aOR, 1.70; 95% CI: 1.08 to 2.67). CONCLUSIONS: One in five men missed two consecutive follow-up visits during this HIV prevention study despite intensive retention efforts and compensation for travel and participation. Participants with recent community arrival may require special support to optimize their retention in HIV prevention activities. Live-in partners of participants may be enlisted to support greater engagement in prevention programmes, and men who engage in transactional sex will need enhanced counselling and support to stay in longitudinal studies.

The UNAIDS 90-90-90 target has prioritized achieving high rates of viral suppression. We identified factors associated with viral suppression among HIV-positive gay, bisexual, and other men who have sex with men (GBMSM) in Kisumu, Kenya. HIV-positive participants in the Anza Mapema study were offered antiretroviral therapy (ART) regardless of CD4 count. HIV viral load was assessed at baseline and after 6 and 12 months of follow-up. Viral suppression was defined as <1,000 copies/mL. Sociodemographic, sexual behaviors, and psychosocial characteristics were assessed via audio computer-assisted self interview. We used generalized estimating equations to estimate the associations between baseline and time-dependent predictors and viral suppression at 6 and 12 months. Seventy-five HIV-positive men were enrolled in the Anza Mapema study, of which 63 had at least one viral load measured during follow-up. Among 52 men with a viral load measure at month 6, 37 (71%) were on ART and virally suppressed. Among 59 men with a viral load measure at month 12, 37 (63%) were on ART and virally suppressed. In the final multivariable model, men who reported receptive or versatile sexual position during anal intercourse with a male partner had reduced odds of viral suppression (aOR = 0.20; 95% CI: 0.08-0.50). Greater levels of coping self-efficacy were associated with increased odds of viral suppression (aOR = 1.10; 95% CI: 1.03-1.16). Despite extensive initiation, retention, and adherence support, the rate of viral suppression in this population did not meet the UNAIDS 90-90-90 target (81% for individuals aware of their HIV status). Pervasive stigma against male-male sex, especially men who practice receptive anal sex, may underlie our findings, which highlight the need for advocacy and stigma reduction efforts. Because coping self-efficacy was a protective factor, efforts to promote resilience in addition to healthy sexual identity development may lead to improved care outcomes among GBMSM in this area.

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: HIV disease staging with referral laboratory-based CD4 cell count testing is a key barrier to the initiation of antiretroviral treatment (ART). Point-of-care CD4 cell counts can improve linkage to HIV care among people living with HIV, but its effect has not been assessed with a randomised controlled trial in the context of home-based HIV counselling and testing (HBCT). METHODS: We did a two-arm, cluster-randomised, controlled efficacy trial in two districts of western Kenya with ongoing HBCT. Housing compounds were randomly assigned (1:1) to point-of-care CD4 cell counts (366 compounds with 417 participants) or standard-of-care (318 compounds with 353 participants) CD4 cell counts done at one of three referral laboratories serving the study catchment area. In each compound, we enrolled people with HIV not engaged in care in the previous 6 months. All participants received post-test counselling and referral for HIV care. Point-of-care test participants received additional counselling on the result, including ART eligibility if CD4 was less than 350 cells per muL, the cutoff in Kenyan guidelines. Participants were interviewed 6 months after enrolment to ascertain whether they sought HIV care, verified through chart reviews at 23 local clinics. The prevalence of loss to follow-up at 6 months (LTFU) was listed as the main outcome in the study protocol. We analysed linkage to care at 6 months (defined as 1-LTFU) as the primary outcome. All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02515149. FINDINGS: We enrolled 770 participants between July 1, 2013, and Feb 28, 2014. 692 (90%) had verified linkage to care status and 78 (10%) were lost to follow-up. Of 371 participants in the point-of-care group, 215 (58%) had linked to care within 6 months versus 108 (34%) of 321 in the standard-of-care group (Cox proportional multivariable hazard ratio [HR] 2.14, 95% CI 1.67-2.74; log rank p<0.0001). INTERPRETATION: Point-of-care CD4 cell counts in a resource-limited HBCT setting doubled linkage to care and thereby improved ART initiation. Given the substantial economic and logistic hindrances to providing ART for all people with HIV in resource-limited settings in the near term, point of care CD4 cell counts might have a role in prioritising care and improving linkage to care. FUNDING: US Centers for Disease Control and Prevention.

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.

Men who have sex with men (MSM) are a crucial and marginalized at risk population for HIV in Africa but are poorly studied. Like other areas of Africa, homosexuality is illegal in Kenya. We assessed MSM comfort in accessing health services and willingness to participate in HIV prevention research in Kisumu, Kenya-an area of high HIV prevalence. We conducted a two-phase formative study with individual interviews (n = 15) and a structured survey (n = 51). Peer contact or snowball method (n = 43, 84.3%) was the primary recruitment strategy used to locate MSM. Exact logistic regression models were used for survey data analysis. Over 60% (32/51) of survey participants were not very comfortable seeking health services from a public hospital. Almost all MSM (49/51; 96.1%) reported willingness to be contacted to participate in future HIV research studies. Efforts to provide facilities that offer safe and confidential health services and health education for MSM is required. Continued community engagement with the MSM population in Kenya is needed to guide best practices for involving them in HIV prevention research.

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.

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.

Men who have sex with men are an important yet marginalised population for HIV prevention in Africa. We conducted a two-phase study (individual qualitative interviews and a survey) of men who have sex with men, aged 18-34 years of age and living in Kisumu, Kenya. Approximately half (27/51) of survey respondents reported belonging to a support group. The odds of belonging to support groups were greater for older men (aged 24-34 versus 18-23 years [OR = 5.20; 95% CI = 1.27-26.66]). More than two-thirds (68.6%) of survey respondents were categorised as having high knowledge of HIV-risk factors. Most respondents (94.1%) correctly reported lack of condom use during vaginal sex as a risk factor for HIV, but slightly fewer (82.4%) recognised lack of condom use during anal sex as an HIV risk factor. Among the 15 interviewees, the following were included as greatest needs: health information (n = 5), safe lubricants (n = 5), condoms (n = 4), healthcare facility or men-who-have-sex-with-men-friendly health services (n = 3) and advocacy (n = 2). Kenyan men who have sex with men have developed support groups and have unmet needs for information, lubricants and condoms and services. Partnering with support groups offers an opportunity for organisations to reach men who have sex with men with accurate health information, provision of safe sexual lubricants, condoms and other health and social services.

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.

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.