1. Referral of participants for HIV follow-up care Africa Centre MDP experiences Presented by: Hlengiwe Ndlovu MDP Clinic coordinator

2. Microbicide Development Programme (MDP) MDP301: Multicentre, double-blind placebo controlled phase III clinical trial evaluating the safety and efficacy of 0.5% and 2% PRO2000/5 gel in the prevention of vaginally acquired HIV. Stopped evaluation of 2% PRO2000/5 in February 2008 due to futility. MDP301 conducted at 6 sites.

3. Africa Centre for Health and Population Studies Africa Centre for Health and Population Studies is a Demographic Surveillance Site funded by the Wellcome Trust. Demographic, socio-economic, sexual behaviour and mortality is collected at least annually across the DSA which is 435km 2 and includes over 85,000 people.

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

5. PEPFAR & DH ART programme initiated in 2003 Started with 1 clinic but services now available in all 15 clinics across the sub-district Approx 5,000 people on treatment

6. HIV+ at screening

7. Screening: ineligible Ineligible – due to HIV status Counselling includes info on benefits of CD4 tests and treatment CD4 test – collect results in 4 weeks –Our monitoring of return for results was inefficient and central registers not always completed –Next visit Provision of ongoing counselling & couple counselling –Very poor uptake Referral letter to DH ART programme –CD4 <250 - Immediately –CD4>250 & <500 – within 3-6 months (if unwell sooner) –CD4 >500 – within 1 year (if unwell sooner)

8. Volunteers screened out 1662 volunteers screened –461 HIV+ (28%) Previously unaware of status CD4 count (410 results) –Range: 18-1,655 –Median: 411 –Mean: 268 37 women <200 and eligible for treatment

9. Benefits of Referral system ART initiation and follow-up clinics now available in same grounds as all MDP clinics (since this year) MDP clinicians volunteer twice a month with ART clinic ART clinics in process of establishing pre- treatment cohorts – now refer all HIV+ women regardless of CD4 count

10. Challenges of Referral system Aim was to monitor uptake of referral by checking referral letters in ART clinics –ART clinics don’t keep central record of referrals – referral letters in patient files only –Women rarely submit referral letters as clinics are walk in –We hoped to use the ID numbers to check the ART database to monitor referral Women have to submit ID to enrol but we don’t always have them at screening; Only patients CD4 count recorded so if used MDP CD4 count not on database; Plus database per clinic and women may attend other clinics outside of area. Agreed to provide CD4 count at start of trial as ART programme was new and concerned about being over burdening. –By getting CD4 count in MDP clinic reduces need to attend ART clinic and get registered; –Women rarely take MDP CD4 counts to ART clinic so test repeated. New results slip in development

11. Monitoring referral Failed to monitor via ART clinics Piloted system of contacting all women with CD4 <250 by phone –Had 44 women on list –Could only contact 18 (41%) Phone numbers change regularly –Only 6 had started treatment (33%) 1 was on TB treatment 3 had contact with clinic but not initiated Remaining either not interested, claimed had not had time to go, or moved out of area (no reason to not access treatment). Aware of 1 women who died (CD4 count=18)

12. Future Monitoring Plan is to create mobile team of doctor, nurse, and tracker to contact all women screened out in order to encourage ART clinic attendance –Phone contacts given at screening not reliable –Population highly mobile so home addresses not reliable Morbidity often trigger for migration to other family household –Difficult to explain to family members present why we are trying to track them i.e. confidentiality –Pre-treatment cohort starting, but offers few benefits so difficult to motivate for women to attend if had high CD4 count in last 6 months.

13. Sero-converters

14. ART clinics throughout area with free access When to give CD4 count? –At time of sero-conversion? –At end of follow-up? What if within 6 months of sero- conversion? Note participants remain in trial after sero-conversion and receive 4 weekly counselling Why do we want to give CD4 tests to sero-converters who are unlikely to be ready for treatment for 5+ years? –In SA health care there are no clinical benefits to participant of knowing CD4 count in first year –Is it a means to familiarise participants with regular CD4 testing? Or does doing tests at MDP clinics reduce need for participant to access ART clinics?

15. Monitoring Referral of sero-converters –How to monitor effectively? –If not ready for initiation then 6 monthly CD4 testing only – how to motivate participants?

16. Additional Challenges Readiness for positive result –Women expect to be HIV- and enrolled in study Stigma –Despite high prevalence stigma remains endemic – often prevents people from accepting result and accessing treatment Visibility at ART clinics Low levels of disclosure – little support Illness based health seeking attitudes –Not likely to attend health care until sick Traditional Healers –People still believe in traditional health care over biomedical health care – therefore often first point of contact until too sick. Political environment –Confusing messages at a national level re HIV and ART Access –It is free but only available Monday to Friday

17. Thank you