stigma, social risk, study design, posttrial obligations, HIV/AIDS, MSM, open-label single arm pilot study, HIV, and MSM
In one Southeast Asian country that is ethnically and religiously diverse, HIV is concentrated among individuals from certain populations. Recently, HIV transmission in this country has shifted. Since 2010, sexual activity has surpassed injection drug use as the most commonly reported route of infection.1,2 Research in this country shows that men who have sex with men (MSM) are at high risk for HIV infection, have low levels of HIV knowledge, and high levels of unprotected anal sex, group sex, multiple partnerships, and recreational drug use before and during sex.3 Stigma is a particularly strong barrier to HIV care access, since both civil and religious laws criminalize same-sex relations, which contributes to low HIV testing rates among MSM. Therefore, many MSM who are infected may not be aware of their infection status. Late diagnosis of HIV-positivity in health care facilities is common among MSM patients, and many are reluctant to disclose their HIV status to family members.
Recent studies have demonstrated the safety and efficacy of dual antiretroviral oral preexposure prophylaxis (PrEP) for preventing sexual and parenteral transmission of HIV infection. Due to recent trends in HIV transmission and the rise of new HIV cases among MSM, this country’s national strategic plan to end AIDS indicated the need to consider PrEP and postexposure interventions for HIV prevention in affected populations. The government aimed to evaluate the delivery of HIV PrEP. Adhering to global HIV PrEP guidelines, a pilot program was launched at three MSM-friendly clinics in the capital city to deliver a comprehensive HIV prevention package targeted to MSM. The overall goal of this pilot project was to deliver, evaluate, and document acceptability and feasibility of HIV PrEP services for MSM. Secondary objectives were to 1) assess eligibility and uptake of HIV PrEP among MSM, 2) determine PrEP adherence and HIV risk behavior, 3) collect self-reports of project-related stigma and discrimination, 4) assess the prevalence and incidence of HIV and other sexually transmitted infections (and provide treatment and referral services), and 5) determine and characterize breakthrough HIV infections. Health officials hoped that clinics taking part in the project might serve as a model and training ground for health care workers and volunteers to become more familiar and comfortable with HIV prevention approaches.
As an open-label, single-arm, prospective study, there was no control group. After being screened, MSM interested in taking part were offered enrollment in the project. Those eligible were 18 years or older, citizens of the country residing in its capital city, committed to participation for 1 year, and HIV-negative. At the onset of the screening, prospective participants received PrEP education and were asked to read and sign an informed consent document. Enrolled participants received additional PrEP educational materials.
There was no compensation for participants other than free access to the evidence-based PrEP, which was not widely available through the public health care system and only available for a fee through private practice. Study participants also had early access to medical care, psychosocial support, and free treatment if they tested positive for HIV. All participants received information about HIV risk-reduction, including free condoms and lubricants, and free testing for other sexually transmitted infections. Health officials in this county hoped the pilot project would bridge the divide between clinical trials showing efficacy of PrEP and service delivery in primary care settings. Upon completion of the 12-month project, participants were offered admission to a self-pay HIV PrEP program or could opt to stop taking PrEP.
Questions
Given the challenges associated with offering PrEP to MSM in the country, is it justified to pilot the study in only three MSM-friendly clinics in the capital city of this country before scale-up?
Given the prevalence of stigma against MSM and people with HIV infection, does study participation risk disclosure of same-sex behavior and HIV risk? Is there any possibility that the study might provoke negative reactions or undue pressures in social, professional, and family environments? What might the researchers do to minimize this risk?
Upon completion of the 12-month project, participants were offered a self-pay HIV PrEP program or the chance to stop taking PrEP. Does this suffice to meet the posttrial obligations to participants and the community connected to the study? Why or why not?
