This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral preexposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

BackgroundLittle is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW).Methods/Principal FindingsMSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2∶1∶2∶1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63–92] for daily dosing and 55% [IQR:28–78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14–50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.Conclusions/SignificanceAdherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.Trial RegistrationClinicalTrials.gov NCT00971230

BackgroundWhile HIV testing and counselling is a key entry point for treatment as prevention, over half of HIV-infected adults in Kenya are unaware they are infected. Offering HIV self-testing (HST) at community pharmacies may enhance detection of undiagnosed infections. We assessed the feasibility of pharmacy-based HST in Coastal Kenya.MethodsStaff at five pharmacies, supported by on-site research assistants, recruited adult clients (≥18 years) seeking services indicative of HIV risk. Participants were offered oral HST kits (OraQuick®) at US$1 per test. Within one week of buying a test, participants were contacted for post-test data collection and counselling. The primary outcome was test uptake, defined as the proportion of invited clients who bought tests. Views of participating pharmacy staff were solicited in feedback sessions during and after the study.ResultsBetween November 2015 and April 2016, 463 clients were invited to participate; 174 (38%) were enrolled; and 161 (35% [95% Confidence Interval (CI) 31–39%]) bought a test. Uptake was higher among clients seeking HIV testing compared to those seeking other services (84% vs. 11%, adjusted risk ratio 6.9 [95% CI 4.9–9.8]). Only 4% of non-testers (11/302) stated inability to pay as the reason they did not take up the test. All but one tester reported the process was easy (29%) or very easy (70%). Demand for HST kits persisted after the study and participating service providers expressed interest in continuing to offer the service.ConclusionsPharmacy HST is feasible in Kenya and may be in high demand. The uptake pattern observed suggests that a client-initiated approach is more feasible compared to pharmacy-initiated testing. Price is unlikely to be a barrier if set at about US$1 per test. Further implementation research is required to assess uptake, yield, and linkage to care on a larger scale.

BackgroundFollowing HIV-1 acquisition, many individuals develop an acute retroviral syndrome and a majority seek care. Available antibody testing cannot detect an acute HIV infection, but repeat testing after 2–4 weeks may detect seroconversion. We assessed the effect of appointment reminders on attendance for repeat HIV testing.MethodsWe enrolled, in a randomized controlled trial, 18–29 year old patients evaluated for acute HIV infection at five sites in Coastal Kenya (ClinicalTrials.gov NCT01876199). Participants were allocated 1:1 to either standard appointment (a dated appointment card) or enhanced appointment (a dated appointment card plus SMS and phone call reminders, or in-person reminders for participants without a phone). The primary outcome was visit attendance, i.e., the proportion of participants attending the repeat test visit. Factors associated with attendance were examined by bivariable and multivariable logistic regression.Principal FindingsBetween April and July 2013, 410 participants were randomized. Attendance was 41% (85/207) for the standard group and 59% (117/199) for the enhanced group, for a relative risk of 1.4 [95% Confidence Interval, CI, 1.2–1.7].Higher attendance was independently associated with older age, study site, and report of transactional sex in past month. Lower attendance was associated with reporting multiple partners in the past two months.ConclusionsAppointment reminders through SMS, phone calls and in-person reminders increased the uptake of repeat HIV test by forty percent. This low-cost intervention could facilitate detection of acute HIV infections and uptake of recommended repeat testing.Trial RegistrationClinicaltrials.gov NCT01876199

Objectives In many African settings, MSM are a stigmatized group whose access to and engagement in HIV care may be challenging. Our aim was to design a targeted, culturally appropriate intervention to promote care engagement and antiretroviral therapy (ART) adherence for MSM in coastal Kenya, and describe intervention safety, feasibility, and acceptability based upon a small pilot study. Design Based on qualitative work including in-depth interviews with HIV-positive MSM and focus groups with providers, we developed a tailored intervention and conducted a pilot test to refine intervention materials and procedures. Methods The Shikamana intervention combines modified Next-Step Counseling by trained providers, support from a trained peer navigator, and tailored use of SMS messaging, phone calls, and discrete pill carriers. Providers, including counselors and clinicians, work together with peer navigators as a case management team. Results Forty HIV-positive MSM aged 19–51 participated in intervention development and testing. Six counselors, three clinical officers, and four MSM peers were trained in intervention procedures. Of 10 ART-naïve participants who enrolled in the pilot, eight completed follow-up with no adverse events reported. One participant was lost to follow-up after 2 months and another failed to initiate ART despite ongoing counseling. No adverse events were reported. Staff feedback and exit interviews rated the intervention as feasible and acceptable. Conclusion This adherence support intervention tailored for Kenyan MSM was well tolerated, feasible, and acceptable in the pilot phase. A randomized controlled trial of a scaled-up programme to estimate intervention efficacy is ongoing.

African men who have sex with men (MSM) face significant stigma and barriers to care. We investigated antiretroviral therapy (ART) adherence among high-risk adults, including MSM, participating in a clinic-based cohort. Survival analysis was used to compare attrition across patient groups. Differences in adherence, weight gain, and CD4 counts after ART initiation were assessed. Among 250 HIV-1-seropositive adults, including 108 MSM, 15 heterosexual men, and 127 women, patient group was not associated with attrition. Among 58 participants who were followed on ART, 40 % of MSM had less than 95 % adherence, versus 28.6 % of heterosexual men and 11.5 % of women. Although MSM gained less weight after ART initiation than women (adjusted difference −3.5 kg/year), CD4 counts did not differ. More data are needed on barriers to adherence and clinical outcomes among African MSM, to ensure that MSM can access care and derive treatment and prevention benefits from ART.

HIV-positive Kenyan men who have sex with men (MSM) are a highly stigmatized group facing barriers to care engagement and antiretroviral therapy (ART) adherence. Because care providers' views are important in improving outcomes, we sought the perspective of those serving MSM patients on how to optimize ART adherence in a setting where same-sex behavior is criminalized. We conducted 4 focus group discussions with a total of 29 healthcare workers (HCWs) experienced in providing HIV care to MSM. The semistructured, open-ended topic guide used was based on an access-information-motivation-proximal cues model of adherence, with added focus on trust in providers, stigma, and discrimination. Detailed facilitator notes and transcripts were translated into English and reviewed for common themes. The HCW identified adherence challenges of MSM patients that are similar to those of the general population, including HIV-related stigma and lack of disclosure. In addition, HCWs noted challenges specific to MSM, such as lack of access to MSM-friendly health services, economic and social challenges due to stigma, difficult relationships with care providers, and discrimination at the clinic and in the community. HCWs recommended clinic staff sensitivity training, use of trained MSM peer navigators, and stigma reduction in the community as interventions that might improve adherence and health outcomes for MSM. Despite noting MSM-specific barriers, HCWs recommended strategies for improving HIV care for MSM in rights-constrained settings that merit future research attention. Most likely, multilevel interventions incorporating both individual and structural factors will be necessary.

A qualitative assessment of Kenyan men who have sex with men taking daily and intermittent oral HIV pre-exposure prophylaxis (PrEP) found stigma, sex work, mobility, and alcohol impacted adherence. We analyzed quantitative data from the same cohort to explore different definitions of intermittent adherence. Volunteers were randomized to daily emtricitabine/tenofovir or placebo, or intermittent (prescription: Mondays/Fridays/after sex, maximum 1 dose/day) emtricitabine/tenofovir or placebo (2:1:2:1), and followed for 4 months. By electronic monitoring, median adherence for daily dosing was 80 %. Median adherence for intermittent dosing was 71 % per a “relaxed” definition (accounting for off-prescription dosing) and 40 % per a “strict” definition (limited to the prescription). Factors associated with lower adherence included travel, transactional sex, and longer follow-up; higher adherence was associated with daily dosing and an income. The definition of intermittent dosing strongly affects interpretation of adherence. These findings suggest interventions should address challenges of mobility, sex work, and long-term PrEP.Electronic supplementary materialThe online version of this article (doi:10.1007/s10461-014-0958-x) contains supplementary material, which is available to authorized users.