1. First Hand Perspective of working on a Microbicides Phase111 Trial Misiwe Mzimela: Social Science Coordinator at Africa Centre

2. Our facilities at one clinic

3. Outline Misiwe as Social Science Coordinator The Microbicides Trial at AC The Strategies Staff Community Engagement Social Science Unit My perfect day Women in the trial Why this trial site?

4. The Role of the SS Coordinator Recruitment, training and Management of social science research assistants. Co-ordination of Participant involvement Managing social science Unit’s operational activities Social Science Data management including collection, quality assurance and control, and archiving Conducting qualitative interviews and transcribing and translating the interviews; Coordinating the social science units’ responsibilities of tracking participants in coordination with the tracking supervisor. Manage quality assurance and quality control procedures; Produce operational and data reports;

5. Microbicides Trial at AC Phase 111 trial product is PRO2000/5 at 0.5% and 2% concentrations against placebo. Design: Randomised, double-blind, placebo controlled. Sample size: 1200 HIV negative women for AC site (7673 across 6 sites) Outcome Measures: Efficacy and Safety

6. Strategies Recruitment – general (Reproductive Health Events) and specific (District Health clinics). One- on-one Information session- info sheet; flipchart; applicator; critical messages; Informed consent (IC) Screening process: Case record forms; eligibility checks; IC; pre-test counseling; HIV testing; post-test counseling. Enrolments: Info reiterated; critical messages; Assessment of understanding; IC; eligibility checks; trial number allocation; CRFs; gel and condoms dispensed (if illiterate-witness) Four weekly follow ups – short and long visits Retention strategies – ( defaulters tracked)

7. Staff Clinic staff in 3 clinics include clinic managers, nurses, counselors, office assistant, clinic clerk. Office based staff: Project leader and deputy, Study doctor, pharmacist, coordinators for different units like laboratory, data, community, social science etc. Out of 60 staff members 57 are local and had no prior knowledge of the clinical. Three have used the microbicides data for analysis for their masters degrees. Meetings-unit meetings-MSCC meetings and whole team meetings

8. Community engagement CLO and recruitment coordinator CAB Roadshows Reproductive Health Events Community Meetings Presentations to different stakeholders Partnership with ICORA FM Radio Workshops – male engagement strategy – football tournament sponsorship

9. Social Science Unit 10% of enrolled women randomised to SS. IC – ask permission to contact partner. Diaries and interviews with women and partners by trained RAs on week visits 4,24 and 52. Triangulation of Sexual behaviour data Qualitative data on gel acceptability, understanding and acceptability of IC procedures. (Women’s perspectives of issues like condoms, partner’s views, community views). Home visits tried – to check ability to complete CD, small ethnographic work

10. Social Science Unit cont. Focus Group Discussions (FGDs) – women not randomised to SS; community members – to check community views about study and gel use. Data from FGDs and IDIs help inform clinic procedures and community engagement work. Ongoing staff training – informed by QC

11. What is my day like? Responsible for 5 RAs. This involves recruitment, induction, ongoing training on – SS procedures and guidelines-qualitative interviewing skills- summary database entries- transcription- translations and coding of interviews. Scheduling weekly tasks for RAs Quality control Reports – against targets Presentations Conduct IDIs and FGDs Coding and analysis of data

12. About Women Women like gel in general as it improves their sex life They like the knowledge they gain from study participation They enjoy being involved with a programme that will help future generations – in terms of HIV risk reduction Some have been able to negotiate for condom use – and engage their partners in sex related talks They like the care they receive from - regular HIV testing, pap smear screening, STI treatments and other clinical abnormalities – referrals to health care services. More quotes:

13. About Women cont. Participant event: about 600 attended with 20 partners. Media event: to give knowledge about microbicides to media representatives – re CS closure negative press. Participant’s involvement.

14. Quotes P: Oh. During the first time, it( the gel) is cold, but during the sexual intercourse, it makes you to become more enthusiastic, that is what I have noticed about the gel. It makes you to be happy and enjoy being with your partner. Women 2 P: Ay, it’s nice to use gel. I: It’s nice. Maybe can you give more explanation, how? P: (laughing) When you are inserting it, it is a bit cold, it has that slight coldness, but during sex, ay, sex is more enjoyable. Our sex is more enjoyable, we don’t have a problem with the gel, it is so pleasing. Women 3 P: Yes I like it I: What makes you like the gel? P: If I am having sex with my partner I feel sex more enjoyable and hot Women 4 l: I heard you saying that sex is hot, how can you describe that hotness? P: It means that sex is more enjoyable, I feel the difference. l: Is that the difference we would like to know? P: I enjoy sex because we take longer before we reach climax if one uses the gel.

15. Why this trial site

16. Population Based Sero-Surveillance June 2003 - October 2004 N=13,006 Resident Men 15-54, Women 15-49

17. Why this trial site? Microbicides trials require large numbers of women at risk of vaginally transmitted HIV –High incidence –Relatively stable (non-transient population) –Little or no injection drug use –Anal sex relatively uncommon

18. Why this trial site cont. Feasibility Study –Aim: Assess the feasibility of conducting phase III Microbicides clinical trials at the Africa Centre – assess recruitment and retention rates, HIV & STI prevalence, HIV incidence –Cohort: 453 women enrolled (391 HIV- & 62 HIV+) –Duration: July 2003 to December 2004 Pilot Study –Aim: Optimise study procedures in preparation for the clinical trial including the use of placebo gel in order to assess acceptability of a vaginal gel. –Cohort: 50 HIV- women; 10 men –Duration: July 2005 to October 2005

19. Challenges Truly informed consent-best way to check understanding Managing expectations Overcome legacy of CS closure and defective condoms. Retention targets Avoid male opposition engaging them Preventing women from co-enrolling and sharing gels

20. Community comments Both positive and negative. Think gel will be useful if found effective. Looking forward to long overdue gel. Males want to be informed of gel use. Gel use might cause conflicts within relationships if not disclosed. Like condoms some think that gel will face resistance if received free from clinics. Gel spreads HIV like condoms. Men want their own gel. Gel might cause infertility in the long run.

21. Thank you, Comments and Questions