Promoting HIV/AIDS Evidence-based Decision Making

1. Program Promoting HIV/AIDS Evidence-based Decision Making Naomi Rutenberg, PhD Program Director, Horizons, Population Council

2. Horizons Structure and Organization • Global HIV/AIDS operations research program • 10 years, August 1997 – July 2007 • Funded by USAID: Office of HIV/AIDS, Bureaus and Missions • 25 professional staff in DC, Kenya, Ghana, South Africa, India, and Thailand

3. Horizons Partners • International Center for Research on Women • PATH • Tulane University • International HIV/AIDS Alliance • Johns Hopkins • Family Health International

4. Identifyproblems inHIV/AIDSprograms Field test and evaluateprogram approaches totreatment,prevention, care and support Disseminate research findings to program managers and policy makers Promote utilization of findings for program improvement Objectives

5. Field based, program-oriented research Focus on program solutions under the control of managers Research to guide program design/ implementation Collaborate with NGOs, community groups, universities, FBOs, government Responsive to national HIV/AIDS needs Rapid review and implementation Examine cost of interventions Horizons Approach

6. Guiding OR Questions • WHAT is the program problem? • WHICH interventions work best? • WHY do they work? • WHERE do they work best? • WHO do they affect? • WHAT do they cost? • HOW do they impact on HIV/AIDS?

7. Diagnostic: Identify program problems Intervention: Seek program solutions Evaluative: Measure program impact Cost: Determine cost of impact Types of OR Studies

8. Current HIV/AIDS Focus AreasTreatment, Prevention, Care • Increase ARV coverage and adherence • Reduce stigma and discrimination • Change behavior using ABC approach • Involve private sector • Prevent mother to child transmission • Provide care and support to orphans and PLHA • Assess cost and effectiveness of interventions • Scale-up successful pilot programs

9. 18 Studies • Prevention of mother-to-child transmission of HIV (PMTCT), 9 studies. Naomi Rutenberg, Carolyn Baek • Adherence to antiretroviral therapy, 4 studies. Avina Sarna, Susan Cherop-Kaai, Philip Guest • Changing gender norms among young men, 2 studies. Julie Pulerwitz, Ravi Verma • Health needs of men who have sex with men, 3 studies. Placide Tapsoba, Amadou Moreau, Harriet Birungi, Scott Geibel, Andy Fisher

10. Why these four areas? • Large gaps in our knowledge that prevent us from developing evidence based programs • New technology with ARVs but little real world experience delivering the technology • Important relationship between gender norms and health risks but how to measure this concept and develop operational programs • Health and risk behavior of MSM a neglected topic in Africa

11. Outline • Why is topic important to HIV/AIDS • Focus of Horizons research • Selected findings • Impact of research and scale-up

12. 1. PMTCT Programs • 630,000 children worldwide infected in 2003 • 490,000 children died of AIDS-related causes in 2003 • Short course AZT (1997) and Nevirapine (1999) trials showed that nearly 50% of infant infections could be prevented cheaply • Opportunity to integrate PMTCT into ANC/MCH platform

13. Infection Rates RATE WITH NO INTERVENTION35-40% RATES WITH INTERVENTION • Antiretroviral drugs + extended breastfeeding 15-25% • Antiretroviral drugs + short breastfeeding 10-15% • Antiretroviral drugs + no breastfeeding 9% • Antiretroviral drugs + no breastfeeding + 1-2%cesarean delivery

14. If You Build It, Will They Come? • Multi-site studies to measure use-effectiveness in Kenya and Zambia • Strengthening infant feeding practices in Ndola, Zambia • Evaluation of UN Pilot PMTCT Programs in 11 countries What is the real world “use-effectiveness” of a package of PMTCT services for prevention of vertical transmission?

15. PMTCT Utilization and Infections Averted in Zambia: Targets and Practice

16. Why the “cascade”? • Demand • Do not want to know HIV status • Fear, no cure, depression • No intervention for mother • Concern about stigma • Lack of male and community support • Difficulty in implementing infant feeding options • Supply • Human resources and capacity • Lack of basic ANC and HIV services

17. Strengthening Health Systems and Scale-up • PMTCT needs assessment methodology developed • Patient counseling procedures improved • Supplies and equipment needs identified • Patient and program monitoring systems developed • University-government partnership formed • Curriculum for training health workers developed for Kenya study adopted in other countries • Kenya study basis for national scale-up

18. 2nd Generation PMTCT Studies • Adherence to PMTCT ARVs in Botswana • Evaluation of peer psychosocial support in South Africa • Community based PMTCT in Nairobi, Kenya • Pilot of postnatal services for HIV+ women and infants in Swaziland • Linking PMTCT to ARV care for HIV+ women in India

19. 2. ARV Adherence • High levels of adherence to ARVs (≥ 95%) required for treatment to be successful • Low levels of adherence may increase chances of resistant strains rendering the drug treatment ineffective

20. Focus of Kenya ARV Adherence Research • Randomized controlled two-arm study DAART • Twice weekly follow-up at clinic for first 24 weeks • Routine monthly follow-up for next 24 weeks Non-DAART • Monthly follow-up for 48 weeks • 3 treatment sites and 6 observation sites • Would DAART strategy result in improved adherence to ARVs?

21. ARV Adherence  95%: Self Reports 1-6 months: NS difference between groups

22. ARV Adherence  95%:Pill Counts 1-6 months: DAART 93% vs non-DAART 74%, p = .001

23. Other measures over 6 months, significant within groups, not between • CD4 cell counts more than double in both groups • 5 to 6 Kg. weight gain in both groups • Depression scores in both groups decreased • Quality of life score improve in both groups

24. Impact and Scale Up • Initial adherence results are encouraging. On basis of pill counts, DAART patients achieved 95% adherence • Significant improvements in CD4 counts, weight, depression, and QOL measures in both groups • Now examining viral loads in Mombasa • An adherence manual for trainers produced, 3,000 copies, widely used in Africa and Asia. • Completing studies in Thailand and Zambia that examine adherence and in India looking at paying and non-paying ARV patients.

25. 3. Gender Equity Programs • Increasing awareness that gender role socialization puts women and men at health risk (WHO 2000). • e.g. Peer pressure on males for multiple sexual partners • But, operationally, how to measure gender norms, and what kind of interventions would be effective to change norms and reduce HIV/STI risk.

26. Focus of Brazil Gender Equitable Norms Research • Changing inequitable gender norms of young men in Brazil • Building relationships based on respect, equality, and intimacy rather than sexual conquest • Taking financial and caregiving responsibility for children • Being responsible for reproductive health and disease prevention • Opposing intimate partner violence

27. HIV/STI Risk at Baseline

28. Change in Reported STI Symptoms * * * *p < 0.05 - Chi-square test, No significant change in control group

29. Change in Condom Use at Last Sex * *p < 0.05 - Chi-square test, No significant change in control group

30. “Used to be when I went out with a girl, if we didn’t have sex within two weeks of going out, I would leave her. But now (after the workshops), I think differently. I want to construct something (a relationship) with her.”

31. Impact and Scale Up • Work in Brazil now replicated in India • Moved from the conceptual level to the operational • Gender equitable scale developed to measure norms • Program interventions can change gender norms • Relationship between gender norms and reduced HIV/STI risk

32. 4. MSM Research in Africa • Little information in Africa about MSM behaviors • Widespread denial about the existence of MSM in Africa • No knowledge about the extent to which MSMbehaviors put men and their partners at risk of HIV infection in Africa

33. Focus of First Senegal MSM Study • Sociodemographic characteristics of MSM • Sexual health risk and prevention behaviors • Sexual health problems • Stigma and discrimination experiences • Health-seeking behavior

34. Selected Findings: Risk Factors Among 250 MSM in Senegal • 88% ever had sex with a woman • 2/3 received money in recent MSM encounter • 43% reported being raped at least once • 13% raped by policeman • 42% experienced genital/anal health problems • 23% used condom at last insertive sex, 14% last receptive sex

35. Focus of Second Senegal Study:Service Utilization May 2003 – March 2005 • 5 providers in Dakar, 1 in each of 4 regions • 774 MSM reached with clinical consultation • 168 requested/referred for VCT • 141 returned for results • 63 HIV- • 78 HIV+ or 10% of all 774 (in a country where the overall prevalence is < 1%) • 50 MSM under treatment, including ARVs

36. Third MSM Study in Kenya Among 500 MSM • 62% reported having sex with at least 1 man in the last week, 90% in last month • 61% reported having anal sex at least 1 time in the last week • 69% have ever had sex with a woman • 59% said they always used condoms • 25-35% ever experienced STI symptoms • 57% had an HIV test, 98% received results

37. Conclusions From Senegal and Kenya • MSM exist in both areas, not negligible • Sexual behavior of MSM also involves women and has reproductive health implications • Condom use is high among MSM in Nairobi, low in Senegal • Sex with multiple partners is high • Many experience discrimination, stigma, and violence • Some receive money or gifts for sex • Confidentiality most important in seeking health care

38. Impact and Scale Up in Africa • Senegal AIDS control commission committed to improving health of MSM and increasing preventive behaviors • MSM component in World Bank Programs for Senegal, The Gambia, and Burkina Faso • Ghana diagnostic study and service provision by USAID Bilateral • Bristol Meyers-Squibb committed to funding MSM interventions in Mali and soon Burkina Faso

39. Final Conclusions • Multiple studies in multiple sites addressing a single topic can identify issues, constraints, and solutions to program problems that a single study might miss. • Impact can be substantial such as influencing an entire country’s scale-up program in Kenya with PMTCT, or focusing donor attention on an important, neglected area such as health and risk behaviors of MSM.

40. Final Conclusions • Tools developed as part of study implementation are important: training curriculum for PMTCT providers, adherence manual for ARV trainers, valid scale to measure gender equity, • Field based studies help shape policies and guide programs on the basis of evidence, not ideology or best guesses.