Incentivizing adherence to pre-exposure prophylaxis for HIV prevention: a randomized pilot trial among male sex workers in Mexico.

Low adherence to preventative medications against life-long health conditions is a major contributor to global morbidity and mortality. We implemented a pilot randomized controlled trial in Mexico to measure the extent to which conditional economic incentives help male sex workers increase their adherence to pre-exposure prophylaxis (PrEP) for HIV prevention. We followed n = 110 male sex workers over 6 months. At each quarterly visit (at months 0, 3, and 6), all workers received a $10 transport reimbursement, a free 3-month PrEP supply, and completed socio-behavioral surveys. The primary outcome was an objective biomarker of medication adherence based on tenofovir (TFV) drug concentration levels in hair collected at each visit. Individuals randomized to the intervention received incentives based on a grading system as a function of PrEP adherence: those with high (> 0.043 ng/mg TFV concentration), medium (0.011 to 0.042 ng/mg), or low (< 0.011 ng/mg) adherence received $20, $10, or $0, respectively. Six-month pooled effects of incentives on PrEP adherence were analyzed using population-averaged gamma generalized estimating equation models. We estimated heterogeneous treatment effects by sex worker characteristics. The incentive intervention led to a 28.7% increase in hair antiretroviral concentration levels over 6 months consistent with increased PrEP adherence (p = 0.05). The effect of incentives on PrEP adherence was greater for male sex workers who were street-based (vs. internet) workers (p < 0.10). These pilot findings suggest that modest conditional economic incentives could be effective, at scale, for improving PrEP adherence among male sex workers, and should be tested in larger implementation trials. ClinicalTrials.gov Identifier: NCT03674983.

Barriers and facilitators to scaling up access to HIV pre-exposure prophylaxis among key populations: A qualitative study of the incentive-based PrEP Seguro program in Mexico.

Introduction: Daily oral pre-exposure prophylaxis (PrEP) is highly safe and effective for HIV prevention, yet barriers to PrEP access and adherence persist among key populations. In Mexico, incentive-based pilot programs have been effective in improving PrEP adherence among male sex workers. Understanding the experiences of providers and program implementers is critical to integrating PrEP adherence programs as part of standard care in Mexico and similar settings. Methods: We conducted 17 in-depth informational interviews with care providers and staff responsible for administering PrEP to key populations (men who have sex with men, male sex workers, transgender women) in Mexico City. Interviews explored successes and challenges surrounding current PrEP implementation, as well as adaptations that could facilitate national scale-up of PrEP programs in Mexico. Informant transcripts were analyzed using a hybrid inductive-deductive thematic analysis approach utilizing CFIR constructs for the initial codebook while allowing for inductive findings. Results: Three key themes emerged from informant interviews as important for promoting PrEP programs in Mexico: 1) increasing individual PrEP access, 2) strengthening quality of care, and 3) improving organizational and structural support. Conclusions: PrEP in Mexico is currently only available in a few clinics with high patient populations, and siloed HIV services, stigma, and a lack of inter-organizational collaboration remain persistent barriers to PrEP uptake. Promoting government collaboration and increasing financial support for community-based organizations is needed to expand PrEP access. Tailored, destigmatizing information about PrEP services needs to be diffused among both staff and patients to strengthen care quality.

Barriers and facilitators to pre-exposure prophylaxis uptake among male sex workers in Mexico: an application of the RE-AIM framework.

BACKGROUND: The ImPrEP México demonstration project is the first to distribute free HIV pre-exposure prophylaxis (PrEP) to men who have sex with men (MSM) and transgender women living in Mexico. In Mexico City, MSM who are also male sex workers (MSWs) face a disproportionately high risk of HIV infection. PrEP is highly effective for HIV prevention, yet "real-life" implementation among MSWs is a challenge due to the unique adherence barriers faced by this population. METHODS: This study uses the RE-AIM implementation science framework to characterize the unique barriers to and facilitators of PrEP uptake among MSWs in Mexico City. We conducted 9 in-depth key informant interviews and 2 focus group discussions with MSWs across 5 clinic and community sites. Qualitative data were analyzed using inductive, open coding approaches from grounded theory. We supplemented findings from the primary qualitative analysis with quantitative indicators derived from ImPrEP program records to describe the current Reach of the ImPrEP program among MSWs in Mexico City and the potential for wider PrEP Adoption among other high-risk populations in Mexico. RESULTS: The Reach of the ImPrEP program was 10% of known HIV-negative MSWs in Mexico City. Program Reach was lowest among MSWs who were street-based sex workers, of lower socioeconomic status, migrants from other states and self-identified as heterosexual. Barriers to program Reach included limited PrEP knowledge, HIV-related stigma, and structural barriers; facilitators included in-person program recruitment, patient-centered care, and spread of information through word of mouth among MSWs. Two out of the four eligible institutions had adopted the ImPrEP protocol. Barriers to wider program Adoption included HIV- and sexual identity- related stigma, protocol limitations, and lack of a national policy for PrEP distribution; facilitators of Adoption included existing healthcare infrastructure, sensitized providers, and community support from non-governmental organizations. CONCLUSIONS: Increasing the ImPrEP program's Reach among MSWs will depend on improving PrEP education and addressing HIV-related stigma and access barriers. Future Adoption of the ImPrEP program should build on existing clinical infrastructure and community support. Creation of a national policy for PrEP distribution may improve the Reach and Adoption of PrEP among highest-risk populations in Mexico.

Incidence and time-varying predictors of HIV and sexually transmitted infections among male sex workers in Mexico City.

BACKGROUND: Male sex workers are at high-risk for acquisition of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). We quantified incidence rates of STIs and identified their time-varying predictors among male sex workers in Mexico City. METHODS: From January 2012 to May 2014, male sex workers recruited from the largest HIV clinic and community sites in Mexico City were tested for chlamydia, gonorrhea, syphilis, hepatitis, and HIV at baseline, 6-months, and 12-months. Incidence rates with 95% bootstrapped confidence limits were calculated. We examined potential time-varying predictors using generalized estimating equations for a population averaged model. RESULTS: Among 227 male sex workers, median age was 24 and baseline HIV prevalence was 32%. Incidence rates (per 100 person-years) were as follows: HIV [5.23; 95% confidence interval (CI): 2.15-10.31], chlamydia (5.15; 95% CI: 2.58-9.34), gonorrhea (3.93; 95% CI: 1.88-7.83), syphilis (13.04; 95% CI: 8.24-19.94), hepatitis B (2.11; 95% CI: 0.53-4.89), hepatitis C (0.95; 95% CI: 0.00-3.16), any STI except HIV (30.99; 95% CI: 21.73-40.26), and any STI including HIV (50.08; 95% CI: 37.60-62.55). In the multivariable-adjusted model, incident STI (excluding HIV) were lower among those who reported consistently using condoms during anal and vaginal intercourse (odds ratio = 0.03, 95% CI: 0.00-0.68) compared to those who reported inconsistently using condoms during anal and vaginal intercourse. CONCLUSIONS: Incidence of STIs is high among male sex workers in Mexico City. Consistent condom use is an important protective factor for STIs, and should be an important component of interventions to prevent incident infections.