Securing care for seroconverters of an HIV prevention trial: Benin experience with the CONRAD Cellulose Sulfate (CS) P

1. Securing care for seroconverters of an HIV prevention trial: Benin experience with the CONRAD Cellulose Sulfate (CS) Phase III Trial F. Guedou M. Alary L. Van Damme Washington June 19, 2008

2. Overview • Background: • Benin country • HIV care program in Benin • Some characteristics of the study site • Securing HIV care in the context of the CONRAD CS study in Benin site • Provisions • Operationalisation • Isssues and difficulties • Learnt lessons and suggestions

3. BENIN COUNTRY

4. HIV infection in Benin • Population of Benin: 8 millions • HIV prevalence: 2% (2006) • Number of PLWH*: 78,650 (2005 projection) • 9,800 PLWH are on ARV (Dec. 2007) * PLWH = People living with HIV

5. HIV care program in Benin • 34 HIV care centres throughout the country • 5 centers in Cotonou (CONRAD trial site location) • All care centres are controlled by PNLS (definition of guidelines, training of staff, drugs provision and supervision) • So, same standard of care throughout the country

6. HIV care program in Benin (cont.) • Since 2002, HIV care is being provided for free to everyone meeting eligibility criteria • A renewable 5-year program, primarily supported by Global Fund

7. HIV care program in Benin (cont.) • Minimum package: • lab tests • ARV • OI prophylaxis • hygiene and dietary advice • Psycho-social support • 4-month follow-up

8. HIV care program in Benin (cont.) Eligibility criteria for ARV : • CD4 < 200 or • WHO stage 4 or • WHO stage 3 + CD4 between 250 and 350

9. Site description • Comprised 2 clinics: DIST and Waly Diop • Target population were women with multiple partners. Two categories of WMPs: formal CSWs and clandestine ones including barmaids) • Enrolled 218 women, most of whom are foreigners. • 9 seroconversions were recorded

10. Site description (continued) • Since March 2005, DIST clinic has been designated as centre for HIV/AIDS care • The two physicians have being trained for taking care of PLWH. • The study has also hired a social worker for the psycho-social management of HIV positive participants.

11. Securing HIV care for seroconverters of CONRAD CS trial • Provisions to secure care for the trial seroconverters: • CONRAD provided a lump of money (though Government offers HIV care for free with the Global Funds support). • An agreement letter has been signed with authorities of the national AIDS program (PNLS) who committed themselves to take care of seroconverters of the study, even after the study.

12. Development of the agreement • meeting with PNLS authorities during the preparatory phase of the trial • drafting an agreement letter specifying the estimated cost for 5-year care for 10 anticipated seroconverters

13. Operationalisation of the agreement • An agreement protocol with more details has been drafted, reviewed by lawyers and co-signed by PNLS and the research contractor (CHA) before money transfer to PNLS. • Transferring funds to PNLS.

14. Operationalisation of the agreement (cont.) • Some difficulties: • PNLS preferred that responsibility of care be shared rather than being transferred • PNLS Director was changed twice before the trial ended (had taken about 8 months to reach consensus).

15. Some issues/concerns Most of participants are foreigners and would have very likely returned back to their home countries before they reach the stage of (ARV) care. But they may come back to Benin for care if they wish so.

16. Some issues/concerns (Cont.) How could sero-converters be identified later on to benefit from the funds in the event the current free care program will ends? (PNLS is reluctant to the idea of issuing to seroconverters a letter recommending them for free care). We are rather considering the possibility of issuing just a card.

17. Learnt lessons and suggestions More active involvement of potential partner for seconverters care (e.g. trial steering committee including these partners)

18. Thanks for your kind attention Benin Statue