Discontinuation of HIV oral pre-exposure prophylaxis: findings from programmatic surveillance within two general population HIV programs in Nigeria.

BACKGROUND: As oral PrEP scales up in Nigeria, information about uptake, use pattern and client preference in a real-world, implementation setting is invaluable to guide refining service provision and incorporation of oral PrEP and other prevention measures into routine health services. To add to this body of knowledge, our study examines factors associated with discontinuation of PrEP among HIV negative individuals across two large scale programs in Nigeria. METHODS: Using program implementation data from two large-scale HIV projects in Akwa Ibom and Cross River states in Nigeria between January 2020 and July 2021, we used logistic regression to explore factors associated with early discontinuation (i.e., stopping PrEP within one month of starting) among HIV-negative individuals who initiated PrEP in the programs. RESULTS: Of a total of 26,325 clients; 22,034 (84%) discontinued PrEP within the first month. The odds of PrEP discontinuation were higher among clients who enrolled in community-based distribution sites (aOR 2.72; 95% C.I: 2.50-2.96) compared to those who enrolled in program-supported facilities and never married (aOR 1.76; 95% C.I: 1.61-1.92) compared to married clients. Clients who initiated PrEP because of high-risk sexual behaviour (aOR 1.15, 95% C.I 1.03-1.30) or inconsistent use or non-use of condoms (aOR 1.96, 95% C.I 1.60-2.41) had greater odds of discontinuing PrEPthan those who initiated PrEP because they were in a serodifferent relationship. CONCLUSION: The behavioural and demographic factors associated with early discontinuation of PrEP suggest that risk stratification of pre-initiation and follow up counselling may be helpful in raising continuation rates. On the service delivery side, strategies to strengthen follow-up services provided by community-based distribution sites need to be introduced. Overall, the low continuation rate calls for a review of programmatic approaches in provision of PrEP services in Nigeria.

An empiric tool to identify Kenyans living with HIV who will have unsuppressed viremia 18 months following treatment initiation to guide differentiated care models.

BACKGROUND: With the global push towards universal access to Antiretroviral Treatment (ART), patient numbers are increasing, further straining already under-resourced healthcare systems in sub-Saharan Africa. A simple scoring tool could be useful in optimizing differentiated service delivery by identifying individuals likely to have unsuppressed viral load. METHODS: Using existing data of patients accessing ART at public health facilities that were extracted from the Kenya Electronic Medical Record (KenyaEMR) and standard methods of developing a clinical prediction tool; we created and validated a risk scoring tool to identify persons likely to be virally unsuppressed at 18 months post-ART initiation. Data from the KenyaEMR were cleaned, merged and reviewed for completeness. We utilized multivariate modelling to determine key predictors of viral load suppression that could be measured in clinical settings. RESULTS: We assessed clinical reports of 3,968 patients on ART who had been on ART for at least 18 months and had at least one viral load result and were ≥ 18 years old. Of these, the majority (81%) were virally suppressed 18 months post-ART initiation. The final risk score included age, sex, body mass index at HIV diagnosis, number of years of formal education, disclosure status, and duration of time between HIV diagnosis and initiating ART. The maximum risk score was 78; a risk score of ≥22 was associated with unsuppressed viral load (>1000copies/mL). The area under the curve (AUC) for the probability of the risk score to correctly predict unsuppressed viral load was 0.55 (95% CI: 0.52 to 0.56). Internal and external validation showed similar predictive ability. CONCLUSIONS: Routinely collected variables in a public HIV clinic medical record predicts, with modest accuracy, individuals likely to have unsuppressed HIV viremia 18 months after they initiate ART. The use and application of this tool could improve and complement efficiency in differentiated care models for patients on ART.

Use of fertility awareness methods as a component of safer conception for women in HIV-serodifferent relationships in Kenya.

BACKGROUND: For couples affected by HIV, and serodifferent couples in particular, pregnancy desire is often juxtaposed against the risk of HIV transmission between the couple and the potential neonate leading to thinking about measures to minimize risk of HIV transmission. We assess the use of fertility awareness methods [FAM] and evaluate the drivers of alignment between indicators of fertility and sexual behavior among HIV-serodifferent couples desiring pregnancy. METHODS: HIV-serodifferent couples from Thika, Kenya were enrolled into an open-label pilot evaluation of safer conception strategies. Women responded to daily 7-item short message service [SMS] surveys on FAM and sexual activity. Menstrual cycles were categorized as having condomless sex aligned, not aligned, or partially aligned to the predicted peak fertility. We used binomial logit models with generalized estimating equations to assess alignment between condomless sex during peak fertility days and FAM results. We used Cox proportional hazards to compare pregnancy incidence among months with sex and peak fertility aligned and mis-aligned. RESULTS: A total of 6929 SMS surveys across 252 menstrual cycles of 65 women were included. Reporting "sticky" cervical mucus (adjusted odds ratio [aOR]: 2.25, 95% confidence interval [95% CI]: 1.30, 3.90) and positive ovulation prediction kit [OPK] result (aOR: 2.07, 95% CI: 1.11, 3.86) were associated with increased likelihood of alignment of condomless sex during peak fertility. Pregnancy incidence was statistically similar among periods with sex aligned and not aligned with peak fertility. CONCLUSIONS: Among women engaged in a comprehensive safer conception program, a moderate percentage of women aligned condomless sex and predicted peak fertility days at least once. While FAM, particularly cervical mucus and OPK, are an inexpensive option for couples to consider using as a component of their safer conception strategies, antiretroviral-based strategies remain important to minimize risk.

Perceptions of pregnancy occurring among HIV-serodiscordant couples in Kenya.

BACKGROUND: Among HIV serodiscordant couples, most conception involves condomless sex and may confer a period with increased HIV transmission risk if HIV viral load is not suppressed and other precautions are not used. Safer conception strategies enable HIV serodiscordant couples to attain their pregnancy goals while markedly reducing this risk. We explored the perceptions and beliefs held by HIV serodiscordant couples and health care providers concerning pregnancy among HIV serodiscordant couples in Kenya and gathered their thoughts about how these might influence use of safer conception methods. METHODS: We conducted 20 Key Informant Interviews (KIIs) with health care providers offering safer conception counseling and 21 In-Depth Interviews (IDIs) and 4 Focus Group Discussions (FGDs) with members of HIV serodiscordant couples with immediate pregnancy goals in Thika, Kenya. Data were analyzed using an inductive approach that identified two emergent themes: perceptions towards pregnancy among HIV serodiscordant couples and access to safer conception services. RESULTS: The perceptions held by the community towards couples in HIV serodiscordant relationships having children were largely negative. The participants were aware of the increased HIV transmission risk to the HIV uninfected partners while trying to become pregnant. In the community, having biological children was cherished yet the majority of the couples shied away from accessing safer conception services offered at health facilities due to stigma and lack of knowledge of the existence of such services. Some providers had limited knowledge on safer conception strategies and services and consequently discouraged HIV serodiscordant couples from natural conception. CONCLUSIONS: Negative perceptions towards HIV serodiscordant couples becoming pregnant has hindered access to safer conception services. Therefore, there is need to create a supportive environment for HIV serodiscordant couples with fertility intentions that normalizes their desire to have children and informs the community about the availability of safer conception services.

Delivering safer conception services to HIV serodiscordant couples in Kenya: perspectives from healthcare providers and HIV serodiscordant couples.

INTRODUCTION: For HIV serodiscordant couples in resource-limited settings, pregnancy is common despite the risk of sexual and/or perinatal HIV transmission. Some safer conception strategies to reduce HIV transmission during pregnancy attempts are available but often not used for reasons including knowledge, accessibility, preference and others. We sought to understand Kenyan health providers' and HIV serodiscordant couples' perspectives and experiences with safer conception. METHODS: Between August 2015 and March 2016, we conducted key informant interviews (KIIs) with health providers from public and private HIV care and fertility clinics and in-depth interviews (IDIs) and focus group discussions (FGDs) with HIV serodiscordant couples participating in an open-label study of integrated pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) for HIV prevention (the Partners Demonstration Project). An inductive analytic approach identified a number of themes related to experiences with and perceptions of safer conception strategies. RESULTS: We conducted 20 KIIs with health providers, and 21 IDIs and 4 FGDs with HIV serodiscordant couples. HIV clinic providers frequently discussed timed condomless sex and antiretroviral medications while providers at private fertility care centres were more comfortable recommending medically assisted reproduction. Couples experienced with ART and PrEP reported that they were comfortable using these strategies to reduce HIV risk when attempting pregnancy. Timed condomless sex in conjunction with ART and PrEP was a preferred strategy, often owing to them being available for free in public and research clinics, as well as most widely known; however, couples often held inaccurate knowledge of how to identify days with peak fertility in the upcoming menstrual cycle. CONCLUSIONS: Antiretroviral-based HIV prevention is acceptable and accessible to meet the growing demand for safer conception services in Kenya, since medically assisted interventions are currently cost prohibitive. Cross-disciplinary training for health providers would expand confidence in all prevention options and foster the tailoring of counselling to couples' preferences.

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya.

INTRODUCTION: HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing. METHODS: Clinic visits were scheduled quarterly and included in-clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self-test kits were provided for participants to use in the two-month interval between scheduled quarterly clinic visits. Acceptability of HIV self-testing was assessed using both quantitative and qualitative methods. RESULTS: We found that 222 of 226 (98%) HIV-uninfected persons who were offered accepted self-testing. Nearly all (96.8%) reported that using the self-testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self-testing with anyone and almost all (98.7%) the participants did not share the HIV self-testing kits with anyone. Many participants reported that HIV self-testing was empowering and reduced anxiety associated with waiting between clinic HIV tests. CONCLUSION: HIV self-testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.

The Effect of Human Immunodeficiency Virus Prevention and Reproductive Health Text Messages on Human Immunodeficiency Virus Testing Among Young Women in Rural Kenya: A Pilot Study.

BACKGROUND: More than half of human immunodeficiency virus (HIV)-infected individuals in Kenya are unaware of their status, and young women carry a disproportionate burden of incident HIV infections. We sought to determine the effect of an SMS intervention on uptake of HIV testing among female Kenyan college students. METHODS: We conducted a quasi-experimental study to increase HIV testing among women 18 to 24 years old. Four midlevel training colleges in Central Kenya were allocated to have their study participants receive either weekly SMS on HIV and reproductive health topics or no SMS. Monthly 9-question SMS surveys were sent to all participants for 6 months to collect data on HIV testing, sexual behavior, and HIV risk perception. We used multivariate Cox proportional hazards regression to detect differences in the time to the first HIV test reported by women during the study period. RESULTS: We enrolled 600 women between September 2013 and March 2014 of whom 300 received weekly SMS and monthly surveys and 300 received only monthly surveys. On average, women were 21 years of age (interquartile range, 20-22), 71.50% had ever had sex and 72.62% had never tested for HIV. A total of 356 women reported testing for HIV within the 6 months of follow-up: 67% from the intervention arm and 51% from the control arm (hazard ratio, 1.57; 95% confidence interval, 1.28-1.92). CONCLUSIONS: Use of weekly text messages about HIV prevention and reproductive health significantly increased rates of HIV testing among young Kenyan women and would be feasible to implement widely among school populations.