Factors associated with age of first sex among women screened for an observational contraceptive vaginal ring study in Kisumu, Kenya, 2014.

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.

Social and psychological correlates of unprotected anal intercourse among Hispanic-American women: implications for STI/HIV prevention.

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.

Characteristics of African American Women and Their Partners With Perceived Concurrent Partnerships in 4 Rural Counties in the Southeastern U.S.

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.

Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010.

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.

"A man's gonna do what a man wants to do": African American and Hispanic women's perceptions about heterosexual relationships: a qualitative study.

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.

Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya.

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].

"Research participants want to feel they are better off than they were before research was introduced to them": engaging cameroonian rural plantation populations in HIV research.

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.

Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019.

Multipurpose prevention technology intravaginal rings (MPT IVRs) may offer a promising solution for addressing women's multiple sexual and reproductive health needs. We describe MPT IVR acceptability perspectives and examine user experiences of 25 cisgender women aged 18-34 years 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 to no knowledge of or experience with IVRs prior to joining the study. Four MPT IVR themes were identified: physical well-being, 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 http://ClinicalTrials.gov under the identifier NCT03762382.

Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya.

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 (log100.57 and log100.27 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 ß-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.

Barriers and facilitators to HIV testing in primary care among health care providers.

PURPOSE: Human immunodeficiency virus (HIV) is a preventable disease that can have improved outcomes with early diagnosis and treatment. The CDC recommends that HIV testing be incorporated into clinical settings as part of routine medical care. METHODS: Individual, open-ended interviews were conducted with primary care providers and administrators to obtain their views regarding the meaning of routine HIV testing and the barriers and facilitators to implementing routine HIV testing in their respective practices. RESULTS: Most respondents supported routine HIV testing, although their definitions of routine varied. Barriers for providers included time and financial constraints to appropriately conduct HIV counseling and testing and inadequate HIV education and training. Facilitators for implementing routine HIV testing included patients' feelings of empowerment and reduced HIV stigma. CONCLUSIONS: The implementation of routine HIV testing in primary care practices appears to be an acceptable public health intervention. Next steps should include efforts to standardize the definition of routine HIV testing and working with primary care settings to better understand and reduce barriers to routine testing.

High prevalence of sexually transmitted infections among women screened for a contraceptive intravaginal ring study, Kisumu, Kenya, 2014.

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 18­34 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 (21­28), 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 17­19 years, aPR=1.27, 95% CI 1.07­1.51), history of exchange sex (aPR = 2.05, 95% CI 1.07­3.92), sexual intercourse in the past seven days (aPR = 1.17, 95% CI 1.01­1.36), and older age (30­34 versus 18­24 years, aPR = 1.26, 95% CI 1.06­1.48). 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 0.54­0.92). Combination prevention approaches (biomedical, behavioural, social, and structural) tailored to women with diverse risk profiles may help mitigate STI/BV prevalence in this setting.

Non-adherence among women enrolled in a contraceptive vaginal ring use study in Kisumu, Kenya, 2014-2015.

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.

Factors associated with psychological distress among young women in Kisumu, Kenya.

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.

Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use.

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® 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® 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.

How should HIV vaccine efficacy trials be conducted? Diverse U.S. communities speak out.

Developing an effective vaccine remains a critical long-term approach to HIV prevention. Every efficacy trial should be responsive to the concerns of participating communities because the successful development of an HIV preventive vaccine will require long-term involvement of people who have been marginalized and who distrust the government and biomedical research. Using qualitative interviews and purposive sampling, we elicited recommendations regarding how vaccine efficacy trials should be conducted from 90 members of communities that have been disproportionately affected by HIV/AIDS: injection drug users, gay men, and African Americans. The most common recommendation was for complete disclosure of all aspects of the trial. Other themes included participant and community education, who to include in trials, preventing harm, trust, community involvement, researcher attributes, and respect for participants. Developing positive, respectful and collaborative experiences with community members will facilitate vaccine research because negative experiences and unfavorable community reactions can greatly impede success in future trials.

A case-control study of factors associated with HIV infection among black women.

OBJECTIVE: To identify social, behavioral and epidemiologic factors associated with HIV infection among HIV-infected and HIV-uninfected black women residing in North Carolina. DESIGN: A case-control study conducted in August 2004 in North Carolina. METHODS: Cases were 18-40-year-old women with HIV infections diagnosed from 2003-2004. Controls were 18-40-yearold, HIV-negative heterosexually active women recruited from HIV testing sites. Five focus group discussions were also conducted with women not participating in the case-control study. RESULTS: Multivariate analyses of 31 cases and 101 controls showed that HIV-positive women were more likely to receive public assistance [adjusted odds ratio (aOR) 7.3; 95% confidence interval (CI) 2.1, 26.0], to report a history of genital herpes infection (aOR 10.6; 95% CI 2.4, 47.2), and were less likely to have discussed a variety of sexual and behavioral issues relevant to risk of HIV infection with their male partners (aOR 0.6; 95% CI 0.4, 0.8). Focus group participants indicated that financial and social demands created competing challenges for making HIV prevention a priority. CONCLUSIONS: Inadequate communication between black women and their sexual partners may create barriers to sexual and behavioral risk reduction. A multidimensional approach that addresses both biological factors such as herpes infection and socioeconomic factors may be needed to reduce HIV transmission in this population.

Heroin shortage in Coastal Kenya: A rapid assessment and qualitative analysis of heroin users' experiences.

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.

Characteristics of women screened for a contraceptive intravaginal ring study in Kisumu, Kenya, 2014.

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.

Investigation of HIV Incidence Rates in a High-Risk, High-Prevalence Kenyan Population: Potential Lessons for Intervention Trials and Programmatic Strategies.

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.

Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana.

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.