title: Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa.
abstract: BACKGROUND
  Human immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority.
  
  
  OBJECTIVE
  The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa.
  
  
  METHODS
  The project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014.
  
  
  RESULTS
  Preliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape.
  
  
  CONCLUSIONS
  The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).
authors.affiliation: Department of Epidemiology, Emory University, Atlanta, GA, United States. a.d.mcnaghten@emory.edu.
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authors.identifier: http://orcid.org/0000-0002-4749-4365
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authors.lastname: McNaghten
authors.forename: Rachel
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authors.lastname: Kearns
authors.forename: Aaron J
authors.identifier: http://orcid.org/0000-0001-5553-7540
authors.initials: AJ
authors.lastname: Siegler
authors.forename: Nancy
authors.identifier: http://orcid.org/0000-0001-9387-0432
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authors.lastname: Phaswana-Mafuya
authors.forename: Linda-Gail
authors.identifier: http://orcid.org/0000-0002-0755-4386
authors.initials: LG
authors.lastname: Bekker
authors.forename: Rob
authors.identifier: http://orcid.org/0000-0001-6034-2019
authors.initials: R
authors.lastname: Stephenson
authors.forename: Stefan D
authors.identifier: http://orcid.org/0000-0002-5482-2419
authors.initials: SD
authors.lastname: Baral
authors.forename: Ron
authors.identifier: http://orcid.org/0000-0002-8639-3399
authors.initials: R
authors.lastname: Brookmeyer
authors.forename: Clarence S
authors.identifier: http://orcid.org/0000-0003-1601-1516
authors.initials: CS
authors.lastname: Yah
authors.forename: Andrew J
authors.identifier: http://orcid.org/0000-0003-2175-1850
authors.initials: AJ
authors.lastname: Lambert
authors.forename: Benjamin
authors.identifier: http://orcid.org/0000-0002-5975-8284
authors.initials: B
authors.lastname: Brown
authors.forename: Eli
authors.identifier: http://orcid.org/0000-0002-1695-8075
authors.initials: E
authors.lastname: Rosenberg
authors.forename: Mondie
authors.identifier: http://orcid.org/0000-0002-8833-9388
authors.initials: M
authors.lastname: Blalock Tharp
authors.forename: Alex
authors.identifier: http://orcid.org/0000-0002-9182-5598
authors.initials: A
authors.lastname: de Voux
authors.forename: Chris
authors.identifier: http://orcid.org/0000-0003-0665-9124
authors.initials: C
authors.lastname: Beyrer
authors.forename: Patrick S
authors.identifier: http://orcid.org/0000-0002-7728-0587
authors.initials: PS
authors.lastname: Sullivan
keywords: HIV; South Africa; Truvada; prevention & control