Experimental design of couples and individual VCT in three antenatal clinics in Dar es Salaam

1. Experimental design of couples and individual VCT in three antenatal clinics in Dar es Salaam Stan Becker(1) Rose Mlay (2) Hilary Schwandt (1) Elijah Lyamuya (2) 2/2010 Johns Hopkiins Univ. Muhimbili College of Health Sciences

2. Outline • Background • Objective • Conceptual Framework • Hypotheses • Setting and Population • Sample Size • Study Flow Diagram • Data Collection • Analytic Methods • Results • Discussion

3. Where did this study come from? Trained in mathematical demography Attended ICPD 1994 where reproductive health replaced family planning as focus Themes: Women’s rights and men’s responsibilities. Hmm. It takes two! Review paper on couples and reproductive health 1996

5. Background • HIV transmission within married or in-union couples is high in sub-Saharan Africa • HIV VCT traditionally addresses the individual • HIV discordance is high 43% of spouses of HIV+ people on ARVs were HIV- (Were et al. 2006)

6. CVCT Background Couples voluntary counseling and testing (CVCT) has been shown to: • Lead to more protected sexual intercourse (i.e. condom use) than individual VCT (IVCT) • Be more cost effective than IVCT

7. HIV in Tanzania • Knowledge is nearly universal • Heterosexual transmission accounts for 90% of new AIDS cases • HIV prevalence estimated at 5.7%; Women 6.6%; Men 4.6% • HIV prevalence in Dar es Salaam is 9.3% • VCT and received results • Women 33% • Men 24% Source: Tanzania Commission for AIDS (TACAIDS), Zanzibar AIDS Commission (ZAC), National Bureau of Statistics (NBS), Office of the Chief Government Statistician (OCGS), and Macro International Inc. 2008. Tanzania HIV/AIDS and Malaria Indicator Survey 2007-08. Dar es Salaam, Tanzania: TACAIDS, ZAC, NBS, OCGS, and Macro International Inc.

8. Objective To evaluate the acceptance and effectiveness of CVCT relative to IVCT in the context of antenatal care clinics in Dar es Salaam, Tanzania in: 1. Preventing maternal to child transmission (MTCT) 2. Increasing protective behaviors in the couple 3. Minimizing negative marital outcomes

9. Conceptual Framework

10. Hypotheses 1. Offering women CVCT will not decrease their individual acceptance of VCT. 2. For HIV-positive women, compared to those with IVCT, those with CVCT will have: a. Greater use of nevirapine for prevention of MTCT b. Reduced sexual risk behaviors c. Lower domestic violence and marital disruption 3. Women who consent and have CVCT are younger and of higher socio-economic status than those who do not.

11. Setting and Population Setting: Antenatal care clinics in Dar es Salaam Population: Married*, pregnant women up to the 6th month of pregnancy presenting for first antenatal visit at 3 clinics May 2003 to February 2004 Seventh Day Adventist Khoja clinic Tamya clinic Consent for baseline questionnaire and intervention Randomization: alternate women assigned to CVCT or IVCT *married: legal marriage, traditional marriage, or living with the same partner for at least 2 years

12. Formative Research • In-depth interviews and focus group discussions in a nearby clinic • Men • Women • Counselors • Topics covered • Acceptability of CVCT • How to make clinics couple-friendly • Providing test results and counseling to discordant couples • Resolving conflict within couples

13. Results from Qualitative study Underlying theme: dealing with uncertainty Recommendation: Care-givers (medical officer) write a letter to husband asking him to attend ANC with his wife

14. Asking the husbands to come… The letter was given to the woman to from the Medical Officer addressed to the husband, inviting him to come to the clinic to “discuss your pregnant wife’s health as well as that of your unborn child” NOTE: The letter did not explicitly state that the husband would be asked to consent to CVCT

15. Sample Size Needed

16. Ethical Approval Ethical approval was received from the IRB of: • Muhimibili University College of Health Sciences • Johns Hopkins School of Public Health A Data Safety Monitoring Board was appointed to monitor the study: If the proportions of women testing in the two study arms deviated significantly (using likelihood methods), the study randomization would need to be stopped since testing is a necessary precondition for nevirapine therapy for the newborn.

17. Study Participant Flow Married women up to 6 months pregnant presenting at 3 clinics in Dar es Salaam Consent and Collect Baseline Information Randomization CVCT Study Arm IVCT Study Arm Women are asked to return to the clinic with their husbands for CVCT Women receive IVCT Couple returns for CVCT Women return for IVCT Follow up on HIV+ women 3 months after delivery

18. Early Results Low return rate in couple’s arm: so we added carfare as incentive to return. But at later times there were errors in hand tabulations so a continued lower rate in couple’s arm was not documented until very late. (When it was discovered, randomization was stopped and 1.5 year investigation at JHU begun)

19. Results

20. Data Collection Occurred at three time points: • Baseline Questionnaire Immediately following consent, prior to randomization • VCT Form Filled out by counselor after VCT • Follow Up Form HIV Positive women were interviewed about three months after delivery

21. Baseline Questionnaire • Data Collected: • Age • Education • Religion • Parity • Assets • Working status/occupation • Condom knowledge/attitude • HIV knowledge • Domestic violence experience

22. VCT Form Data Collected: Counseling received or not Tested or not Received results or not Test results

23. Follow Up • HIV+ women were asked to return to the clinic 3 months after the expected delivery date • Given transport fares • Interviewer was blind to the woman’s study arm

24. Follow Up Form Data Collected: Baby’s date of birth Mom/Baby health problems HIV knowledge Domestic violence since testing HIV protective behaviors since testing Mom/Baby nevirapine use Breastfeeding status

25. Why we thought husbands would come: Formative research Men were very receptive to the idea of CVCT All consenting women were fully informed of the study procedures Women who did not consent were still offered IVCT High rate of return for ANC visits Tanzania mean = 4

26. Analytical Methods Tests of randomization Intent-to-treat Percentage in each study arm Counseled Tested Received Results With or without male partner for those in the CVCT study arm Z, t and Chi-square tests and ANOVA with F tests Multiple logistic regression Fisher’s exact test

27. Test of Randomization Tabulations to compare background factors by randomized study arm Age Education Parity Assets Working Status Religion

28. Results Randomization was successful All differences between two groups were within sampling error except % knowing someone living with HIV/AIDS or who had died from AIDS related causes (see next slides)

29. CVCT subgroups • CVCT definition: couple receives counseling, testing, and test results together • Subgroups for those randomized to CVCT • Women who completed CVCT • Women who completed IVCT • Women who returned to the clinic but did not complete VCT • Women who did not return

30. Table 1: Characteristics of women randomized to individual or CVCT, and by their actual participation in CVCT in an experimental study in 3 antenatal clinics in Dar es Salaam, Tanzania. Not significant were: number of items owned, working, religion, HIV knowledge, Know where to buy condoms, Ever beaten by husband, Beaten in last 6 months, Beating justified b Complete CVCT is defined here as receiving counseling, testing, and test results as a couple. c IVCT is defined here as receiving one or more of counseling, testing, and/or test results as an individual. d Incomplete VCT is refusing either counseling, testing, or receiving results. * p < 0.05 for test of hypothesis that women in the two randomized study arms are from the same population. † p < 0.05 for the test of hypothesis that the four CVCT subgroups are from the same population.

31. Results 761 women randomized to IVCT 93% agreed to counseling 78% to testing 71% to receive results 760 women randomized to CVCT 33% returned with their partners 15% returned alone 51% did not return See flow chart

33. Results • Among the 33% in the CVCT arm who came as couples: • 47% agreed to counsel, test, and receive test results together

34. Results • 16% of all women randomized to CVCT actually completed CVCT • Including cross-overs (women who received IVCT) in the CVCT arm: • 43% tested • 39% received results

35. Hypothesis 1 Results • Intent-to-treat analysis 71% in IVCT arm completed VCT 39% in CVCT arm completed VCT • A statistically significant difference • Thus, Hypothesis 1 is rejected • But among those in the CVCT arm who returned to the clinic (alone or with their partner) • 80% completed VCT vs. 75% in the IVCT arm

36. HIV Positive Results • 922 women tested 10% were HIV positive (10% in each study arm) • Of those testing HIV positive 87% completed the follow up interview

37. CVCT Selection effects • Selection across the four CVCT subgroups by: • Age • Parity • Years of schooling • Working status • religion

38. 2 CVCT Subgroups Comparing those randomized to CVCT who received CVCT (n=119) and those who did not (n=641), we find: Those who completed CVCT were: ↓ Age ↓ Parity ↓ Muslim ↓ Domestic violence Thus, Hypothesis 2 is partially supported (age)

39. Hypothesis 3: HIV+ Women • HIV+ women in the CVCT arm who completed CVCT (n=11) as compared to HIV+ women in the IVCT arm (n=50) ↓ Marital dissolution ↓ Domestic violence ↑ Mom received Nevirapine (55% vs 24%) ↑ Infant received Nevirapine (55% vs 22%) ↑ Used abstinence or condoms since testing (90% vs 60%) • Results did not reach statistical significance due to the small sample sizes • Hypothesis 3 is partially supported

40. Table 2: Percent of HIV+ women with selected outcomes postpartum reported in follow up survey, by study group. a Includes abstinence and condom use. n = 71; ten women did not respond because they were no longer living with their husbands at the time of follow-up b n = 79 two of the six mothers with infants who had died, did not answer the question about nevirapine. c Complete CVCT is defined here as receiving counseling, testing, and test results as a couple.

41. Limitations • Differences in procedures by study arm: • IVCT study arm received IVCT immediately • CVCT study arm had to ‘fetch’ husband and return to the clinic for VCT

42. Discussion • Only 16% of women randomized to CVCT actually completed CVCT • 51% did not return to the clinic • In a setting where most women return for subsequent ANC visits • 39% in the CVCT arm tested vs 71% in the IVCT arm

43. Discussion • Couple involvement in VCT in sub-Saharan Africa has been low • Particularly with ANC based VCT • Nevirapine use was low in both study arms • Possibly due to concerns about confidentiality

44. Discussion Possibly protective effects seen in CVCT arm for HIV+ women • But very likely due to selection effects

45. Recommendations 1. Community mobilization necessary for increased CVCT 2. CVCT is not for all couples • History of domestic violence? 3. Need settings other than ANC for CVCT services also • Stand alone clinics • Places of work • Home based care 4. Testing rates were similar between the two groups when comparing those in the CVCT arm who returned and those in the IVCT arm Couples should be encouraged to visit testing sites together so testing can occur on the first encounter

46. Thanks to those who provided funding: Center for AIDS Research, JHU Gates Institute, JHU Population Center, JHU Muhimibili University of Health and Allied Sciences