9th INDEPTH AGM, 27th OCT 2009, PUNE INDIA

A community based trial of enhanced family planning outreach in Rakai, Uganda

Tom Lutalo1, Edward Kimera1

Godfrey Kigozi1, Fred Nalugoda1,

David Serwadda1, Maria Wawer2, Laurie Schwab Zabin2, Fred Wabwire-Mangen1, Nelson Sewankambo1, Ron Gray2

1Rakai Health Sciences Program2Johns Hopkins Bloomberg School of Public Health

Outline

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

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

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.

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

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)

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

Non intervention clusters

• Standard national (and NGO) programs of promoting FP services using selected Health Units

• Condoms supplied by RHSP in both arms

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

Socio-demographic and behavioral characteristics in the intervention and non intervention arms at baseline

Baseline (1999/2000)

Intervention Control

(6720) (3574)

Characteristics % % p-valueGender Female 53.9 51.0 Male 46.1 49.0 0.006Communities Rural 80.3 83.4 Peri-Urban 19.7 16.6 <0.0001Age (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 <0.0001Marital Status Not Married 29.0 24.5 Married 71.0 75.5 <0.0001Number of children 0-1 32.2 32.0 2-4 41.0 44.6 5+ 26.8 23.4 0.010---------------------------------------------------------------------------------------------------------------Other characteristics comparedReligion p<0.0001, Education level p=0.246, Sex partners past yr p=0.086

HIV status p=0.158

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) 0

5

10

15

20

25

1999/2000 2003/4

FP clusters Non FP

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)

0

1

2

3

4

5

6

1999/2000 2003/4

FP clustersNon FP

01234567

1999/2000 2003/4

FP clustersNon FP

Rural

Peri-urban

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

0

5

10

15

20

25

1999/2000 2003/4

FP clustersNon FP

0

5

10

15

20

1999/2000 2003/4

FP clustersNon FP

Peri-urban

Rural

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)

0

2

4

6

8

10

12

14

16

18

1999/2000 2003/4

FP clusters Non FP

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

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%)

Summary

• The intervention resulted in

– modest but statistically significant increased use of hormonal contraceptives (pill & injections)

– Lower pregnancy rates in intervention arm

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

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

RHSP Research Center

THANK YOU