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Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa.
JMIR Res Protoc. 2014 Oct 16; 3(4):e55.JR

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

Authors+Show Affiliations

Department of Epidemiology, Emory University, Atlanta, GA, United States. a.d.mcnaghten@emory.edu.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25325296

Citation

McNaghten, Ad, et al. "Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa." JMIR Research Protocols, vol. 3, no. 4, 2014, pp. e55.
McNaghten A, Kearns R, Siegler AJ, et al. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. JMIR Res Protoc. 2014;3(4):e55.
McNaghten, A., Kearns, R., Siegler, A. J., Phaswana-Mafuya, N., Bekker, L. G., Stephenson, R., Baral, S. D., Brookmeyer, R., Yah, C. S., Lambert, A. J., Brown, B., Rosenberg, E., Blalock Tharp, M., de Voux, A., Beyrer, C., & Sullivan, P. S. (2014). Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. JMIR Research Protocols, 3(4), e55. https://doi.org/10.2196/resprot.3737
McNaghten A, et al. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. JMIR Res Protoc. 2014 Oct 16;3(4):e55. PubMed PMID: 25325296.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. AU - McNaghten,Ad, AU - Kearns,Rachel, AU - Siegler,Aaron J, AU - Phaswana-Mafuya,Nancy, AU - Bekker,Linda-Gail, AU - Stephenson,Rob, AU - Baral,Stefan D, AU - Brookmeyer,Ron, AU - Yah,Clarence S, AU - Lambert,Andrew J, AU - Brown,Benjamin, AU - Rosenberg,Eli, AU - Blalock Tharp,Mondie, AU - de Voux,Alex, AU - Beyrer,Chris, AU - Sullivan,Patrick S, Y1 - 2014/10/16/ PY - 2014/07/31/received PY - 2014/09/11/accepted PY - 2014/10/18/entrez PY - 2014/10/18/pubmed PY - 2014/10/18/medline KW - HIV KW - South Africa KW - Truvada KW - prevention & control SP - e55 EP - e55 JF - JMIR research protocols JO - JMIR Res Protoc VL - 3 IS - 4 N2 - 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj). SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/25325296/Sibanye_Methods_for_Prevention_Packages_Program_Project_Protocol:_Pilot_Study_of_HIV_Prevention_Interventions_for_Men_Who_Have_Sex_With_Men_in_South_Africa_ L2 - https://www.researchprotocols.org/2014/4/e55/ DB - PRIME DP - Unbound Medicine ER -