Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa

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).


[Place blank, LAMINATED TIMELINE in front of the participant]
Here is a blank timeline, with "BIRTH" on one end and "TODAY" on the other. At the beginning of the exercise, I will ask you to put various moments on the timeline in the order they occurred in your life. These will be moments related to your sexual activities and relationships. After you're done, I'll ask you some questions about the timeline you made.

[Place Worksheet 1: SAMPLE TIMELINE in front of the participant]
Here's a fictional example of how this activity works. This timeline is about someone's lifetime experience playing football. Let's call this fictional man Sipho.

Sexual Attraction Moment Boxes:
 When you first began to experience samesex attraction  When you first began to experience opposite [Throughout the interview, record the participant's responses on your own timeline by moment and age.

Sexual Attraction
So, I noticed you put samesex attraction/oppositesex attraction here. How old were you when each sexual attraction moment happened?

Probes:
• How did you react to those feelings?
• Describe how this experience changed the way you viewed yourself.
• Did this change the way other people viewed you, and if so, how? Probes: • Were these positive or negative experiences? Why?
• What kinds of challenges did this moment cause for you?
• Please describe the way these experiences changed the way you viewed yourself.
• Did this change the way other people viewed you?

Safer Sex
You say that you began using condoms at this point in time. How old were you when you first learned how to use a condom? How old were you when you actually began using condoms? At what point on your timeline did you begin to use condoms when you had sex with men?

Probes:
• Why did you begin to use condoms?
• Who did you use them with?
• Did you stop using condoms? If so, at what age and why?
• What kinds of challenges did condom use cause for you?
• Please describe the way condom use changed the way you viewed yourself.
• Did your opinion on condom use change the way any partners viewed you?
• Did condom use affect or change your relationship?

Sexual Identity
On your screener form, you told me you call yourself (gay/bisexual/etc. • What kinds of challenges did this experience cause for you?
• Please describe the way your sexual preferences changed the way you viewed yourself.
• How did this change the way other people viewed you, if at all?

Closetedness
Many men who have sex with men talk about their experiences "coming out" to friends and family, that is, telling their friends and family about their sexual identity. What prompted you to come out? [If men excluded one or both of the closetedness Moment Boxes] I don't see experiences of coming out to your friends/family. What kept you from coming out to your friends/family?

Probes:
• At what age did you first tell your friends about your sexual preference?
• At what age did you first tell your family about your sexual identity, if at all?
• What kinds of challenges did this experience cause for you?
• Please describe the way this experience changed the way you viewed yourself, if at all.
• How did this change the way other people viewed you, if at all?

Relationships
Tell me about the relationship moments on your timeline. How old were you when these happened?

Probes:
• Did any of these relationships happen at the same time?
• Did you tell your family/friends/colleagues about your boyfriend/partner/husband?
• Please describe the way this experience changed the way you viewed yourself.
• Did this change the way other people viewed you?

HIV Testing & Treatment Behavior
Now I would like to move on and talk about moments involving HIV testing and treatment. How old were you when each of these moments happened?

Probes:
• What made you decide to get tested?
• Did you tell your family/friends/colleagues about your HIV status?
• Please describe the way this experience changed the way you viewed yourself.
• Did this change the way other people viewed you?
• Did this change the way other people viewed you?

Community Involvement and Everything Else
We're almost finished assembling your timeline. How old were you when each of these remaining moments happened?

Probes:
• What kinds of challenges did these moments cause for you?
• Did this change the way you viewed yourself?
• Did this change the way other people viewed you?

Conclusion + Resilience
Considering all that we've talked about during this timeline activity, it seems like you've overcome a lot of challenges. How did you make it through? Do you have any advice for other men who may have experienced similar moments?
Would you like to take a break before Activity 2?