1. 9th INDEPTH AGM, 27th OCT 2009, PUNE INDIA A community based trial of enhanced family planning outreach in Rakai, Uganda Tom Lutalo 1, Edward Kimera 1 Godfrey Kigozi 1, Fred Nalugoda 1, David Serwadda 1, Maria Wawer 2, Laurie Schwab Zabin 2, Fred Wabwire-Mangen 1, Nelson Sewankambo 1, Ron Gray 2 1 Rakai Health Sciences Program 2 Johns Hopkins Bloomberg School of Public Health

2. Outline What RAKAI does A review of previous findings The objectives of the intervention Community selection The Intervention activities Results Public Health Challenges

4. Background The Rakai Health Sciences Program (RHSP) Since 1994 a cohort of ~12-14,000 adults aged 15-49 yrs has been under annual surveillance RHSP provides health education about STDs & HIV Family planning Abstinence and condom promotion for prevention of STDs and HIV Condoms, which are also provided free of charge or at subsidized prices

5. 1995-99 Cohort and FGD findings Only 13% of women who wanted no more children were using contraceptives 15% of women who wanted to delay pregnancy by >2 yrs were practicing family planning FGD participants were more vocal about perceived health risks of FP than about potential benefits Impediments included women’s access to FP services, costs of contraception and men’s negative attitudes towards FP Identified a need to introduce and evaluate interventions to correct misconceptions, and to improve access to quality services.

6. Rural Rakai

7. Objectives of Intervention Establish and maintain community based outreach programs to improve awareness and utilization of hormonal contraceptives (the pill and injections which are female controlled methods) Evaluate impact of intervention using cohort data –Changes and differences in hormonal contraceptive use and pregnancy rates by study arm

8. Community selection and study period Convenient sampling of 6 clusters nested in 11 clusters (initially) randomized for the RAKAI STD trial The 11 clusters form the RAKAI cohort The intervention was staggered over a three year period (1999 - 2002)

9. Intervention activities Community members identified FP agents and Service Providers who accepted to volunteer RAKAI trained, followed up and continued to retrain volunteers Used HIV counselors at time of HIV result giving Used DRAMA shows with FP themes Programs for in-school, out of school and TBAs Service Delivery –Supplied and equipped volunteers to provide condoms, oral contraceptives and injectables Continued sharing of experiences –Amongst volunteers –Village meetings->Certified Satisfied Users of hormonal contraceptives and condoms testified

10. Non intervention clusters Standard national (and NGO) programs of promoting FP services using selected Health Units Condoms supplied by RHSP in both arms

11. Evaluation of intervention Used RAKAI cohort survey data –Compared promoted contraceptive use at baseline (1999- 2000; RND 6) and after over 30 months follow up (2003-04; RND 9) in FP and non-FP clusters –Pregnancy rates by arm –Chi-square tests of statistical significance for absolute change in contraceptive use by arm –Multivariate adjusted analyses included baseline hormonal contraceptive use, socio-demographic and behavioral characteristics found to differ at baseline and variables thought to be related to hormonal contraceptive use

12. Socio-demographic and behavioral characteristics in the intervention and non intervention arms at baseline Baseline (1999/2000) Intervention Control (6720) (3574) Characteristics % % p-value Gender Female 53.9 51.0 Male 46.1 49.0 0.006 Communities Rural 80.3 83.4 Peri-Urban 19.7 16.6 <0.0001 Age (yrs) 15-19 14.7 12.4 20-29 46.6 48.6 30-39 25.8 28.3 40-49 12.9 10.7 <0.0001 Marital Status Not Married 29.0 24.5 Married 71.0 75.5 <0.0001 Number of children 0-1 32.2 32.0 2-4 41.0 44.6 5+ 26.8 23.4 0.010 --------------------------------------------------------------------------------------------------------------- Other characteristics compared Religion p<0.0001, Education level p=0.246, Sex partners past yr p=0.086 HIV status p=0.158

13. Use of Hormonal Contraceptives between study arms at baseline and follow up Use of hormonal contraceptives was similar at baseline (13.4% Vs 13.8%, p=0.69) At follow up, hormonal contraceptive use was significantly higher in the FP clusters compared to non FP clusters (23.2% Vs 19.9%, p=0.009)

14. Use of oral contraceptives in rural and peri-urban communities at baseline and FUP by study arm At baseline, oral contraceptive prevalence was slightly higher in the intervention arm in both rural and peri-urban areas In the rural areas there was a significant increase in use (p<0.001) in the intervention arm with no change in the non intervention arm Slight increase in use were observed in the peri-urban communities in both study arms (ns) Rural Peri-urban

15. Use of Injectables in rural and peri-Urban Communities by study arm at baseline and FUP There was no change in use in non-intervention peri-urban clusters At FUP there was a significant increase in use observed in the intervention arm (p<0.001) In the rural communities there was an increase in both arms Peri-urban Rural

16. Pregnancy rates between study arms at baseline and follow up Pregnancy rates at baseline were comparable (16.5% Vs 17.6%, p=0.276) At follow up pregnancy rates were significantly lower in the intervention clusters compared to the non intervention clusters (12.5% Vs 14.8%, p=0.024)

17. Multivariate logistic regression Odds of hormonal contraceptive use at follow up were increased in –intervention versus control communities (adj OR 1.33, 95% CI 1.03 – 1.72) –Intervention communities with earlier FP (adj OR=1.36, 95% CI 1.02-1.81) Duration of intervention, education and number of children were strong determinants of hormonal contraceptive use

18. Condom use and adjusted analysis Condom use by males in the two study arms increased significantly between baseline and follow up in the intervention arm (p<0.01) but the increase was not statistically significant in the control arm (Intervention: 30.5% to 33.9%) (Control: 30.1% to 33.0%)

19. Summary The intervention resulted in – modest but statistically significant increased use of hormonal contraceptives (pill & injections) –Lower pregnancy rates in intervention arm

20. Public Health challenges for such an intervention Intensive supervision of the volunteers High turnover rate of volunteers requiring identifying and training of new ones Increase in counseling time by resident HIV counselors for quality FP counseling High demand for modern contraceptives Sustainability –The intervention activities cost 300,000 $ over the three years

21. RHSP appreciates the efforts of; The Gates Institute at Johns Hopkins Bloomberg University (funders of intervention) The RHSP Family Planning Team The PIs and all other staff of RHSP The district teams involved The study volunteers INDEPTH for accepting RAKAI to share experience

22. RHSP Research Center THANK YOU