First Hand Perspective of working on a Microbicides Phase111 Trial

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