The Methods for Improving

Reproductive Health in Africa

(MIRA) Study

SOC PROGRAM

Liz MontgomeryWomen’s Global Health Imperative

RTI InternationalGCM SOC Consultation

June 19, 2008

Partners• Women’s Global Health Imperative: University

of California San Francisco

• Ibis Reproductive Health, USA & RSA

• University of Zimbabwe-UCSF Collaborative Research Programme, Zimbabwe

• Medical Research Council, Durban RSA

• Perinatal HIV Research Unit, Johannesburg, RSA

• Funder: Bill & Melinda Gates Foundation

Study Aims

To examine the effectiveness of the diaphragm and lubricant gel for preventing HIV acquisition in women

•Primary endpoint: HIV acquisition

•Secondary endpoints: cervical STIs (GC & CT)

Study Design

All women received risk reduction counseling, free male condoms and diagnosis and treatment of curable STIs

HIV-negativeSexually active

Non-pregnant women

Dia + gel + condoms Male condoms

+

MIRA Trial Sites

Total n = 5045

UZ-UCSFHarare, Zimbabwen=2502

PHRUSoweto, South African=1028

MRCDurban, South Africa n=1515

Zimbabwe Standard of Care at start of MIRA trial

• ARV’s available only as part of research studies. These are few and small, but UZ-UCSF has direct relationships with the investigators of these studies.

• MOH planned to roll out nationwide generic ART programme at tertiary hospitals, but unknown exactly when this would happen

MIRA: Current Standard of Care

• Screened HIV+ MIRA women:– Professional pre and post-test counseling for woman

and partner– STI screening and treatment for woman and partner– 2-week follow-up supportive counseling visit at MIRA– Referral to social services, support groups and

“moving-on” clubs, HIV care organizations – Referral to research studies providing ART (DART,

Duke) and studies specializing in discordant couples (HPTN 052)

MIRA: Current Standard of Care

• Seroconverters:– Same as screened HIV+ women, except that

seroconverters stay in study, therefore have ongoing access to clinical care for themselves and partners. This includes pregnancy and STI screening and treatment for any medical problems.

Standard of Care

• “Moving target” - National ARV programmes and “standard of care” for research studies evolving as study progressed;– Gates Foundation aware that what they

approved for MIRA would set a precedent– Equity, sustainability huge concerns

MIRA SOC program - theory

• (Official) Overall goal was to transition all MIRA seroconverters into the National ARV Programme in Zimbabwe or South Africa before the end of the trial period (thereby ensuring sustainability)

• Explicitly, we did not plan to assume responsibility for care and treatment

Timeline

MIRA initiated

2003 2004 2005 2006 2007 2008

MIRA SOC initiated

MIRA ended

SOC IE interviews

MIRA SOC – Operationalization

• Durban: MOUs with organizations, clinics and hospitals

• Soweto: Referral to co-located facility with psychosocial support and ART

• Harare: Referral to local psychosocial support and OI clinics (in theory)

• At all sites: referral to ART studies viewed as equivalent to National Tx Programmes

Zimbabwe in reality

• Social welfare> OI clinic/ CD4 testing> ART– CD4 testing done by trial, trial paid for small

subsidy for cost of ART if needed, during study

– Paper at social welfare– National shortages/ slots ran out

• Connections

MIRA Standard of Care Program Results

UZ-UCSF MRC PHRU Total

PROGRAM OVERVIEW        

Total number of seroconverters 125 153 49 327

Received information about SOC from MIRA staff 91 35 22 148

Contacted and did not decline, but never attended SOC visit at MIRA clinic 3 12 10 25

Not interested or LTFU 29 68 14 111

Declined because already participating in similar program for HIV-positives/satisfied with outside care 0 36 3 39

Deceased 2 2 0 4

LINKAGES TO OUTSIDE SERVICES        

Opportunistic Infection facilities        

Referred 80 27 23 130

Enrolled 59 17 8 84

Other research studies        

Referred 13 30 11 54

Enrolled 6 30 11 47

ARV TREATMENT        

Received CD4 test at MIRA-related clinic 87 29 24 140

Accessed ARVs 13 3 2 18

Waitlisted ARVs 3 0 0 3

Summary of linkage success

• Harare: 74%

• Durban: 37%

• Soweto: 69%

• 13 of 300+ accessing ARVs

SOC Challenges

• Country-level: National programmes are new and face challenges of their own – staff shortages, ARV shortages (Zim);

• Study-level: Difficult for research study team to manage a “care” package in a variety of different settings, with varying resources, different relationships with local organizations, and different resources

• Participant-level: Some participants difficult to reach, in denial about serostatus/ need for ARVs, some already passed away by the time SOC implemented

Key unanswered questions

• Why such low uptake

• Where are they now?