The South Africa Men's Health Monitoring Study (SAMHMS): An Integrated Biological Behavioral Survey with Population Size Estimation using Respondent Driven Sampling among men who have sex with men (MSM).
Abstract
This protocol describes study activities among men who have sex with men (MSM) in multiple locations in South Africa to measure HIV prevalence, HIV incidence and related risk behaviors, and access to prevention and care services. The overall approach is based on standardized methods for integrated biological and behavioral surveys (IBBS) used around the world with adaptations for the South African context. A formative assessment phase and multiple methods to estimate the size of MSM are included within the study protocol. The survey will use respondent-driven sampling (RDS) for recruitment of men through peer-referrals using non-identifying codes to link enrolled participants to those whom they refer to the study and collecting social network size data for statistical adjustments. Men age 16 and over that live, work or socialize within study locations may be eligible for this confidential study. In accordance with South African ethical standards, written informed consent will be required. Stringent safeguards will be implemented to restrict access to all study forms and documentation. Further, for the protection of participants, staff will not ask for identification for those agreeing to be part of the study.
Proposed procedures include:
??? administering a risk behavior questionnaire.
??? HIV/STI risk assessment and disclosure counseling.
??? rapid HIV testing with confirmatory testing of positive specimens; persons testing HIV-positive on rapid testing will be referred to collaborating clinics for care and support.
??? quality assurance (QA) testing for HIV using dried blood spot (DBS) at the South Africa NICD.
??? HIV testing of all samples, and incidence testing for all HIV-positive samples, for surveillance purposes at the South Africa NICD.
??? storage of dried blood spot (DBS) for future BED/incidence testing (testing for HIV incidence/new infections within the study sample).
Participants may consent to or decline each part of the study (e.g., survey, rapid testing, DBS cards for incidence testing). Persons testing HIV-positive on rapid testing will be referred to collaborating clinics for care and support services. Five hundred (500) men in five study sites are proposed. The sample size of 500 per location is based on providing 80% power to detect a significant (p<0.05) 10% change in condom use between the proposed survey and future rounds of IBBS using a chi-square test and assuming a design effect of 2.0. Findings of the surveys will be disseminated to stakeholders to advocate for needed services for MSM, develop appropriate prevention and care interventions, guide future research, and assess the impact of the response to the HIV epidemic over time. This project proposal will be submitted for human subjects review and approval at CDC, the The University of Cape Town and the Committee on Human Research of UCSF in the United States.
