Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda

Not Applicable

Completed

• Conditions: HIV Testing and Counseling
• Interventions: Other: FP and HTC services; Other: FP services

• Registration Number: NCT02244398
• Lead Sponsor: FHI 360

Brief Summary

The purpose of this study is to evaluate the feasibility and acceptability of adding HIV testing and counseling (HTC) services to the family planning (FP) services provided by community health workers in Uganda.

Detailed Description

The Uganda Ministry of Health is implementing a Village Health Team strategy whereby lay volunteers, called VHTs, provide a government-endorsed platform for all community-based health programming. Where trained, VHTs already offered family planning services, including injectable contraceptives. In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC). The goal is to reach individuals whose sexual and reproductive health needs may be underserved by clinic-based services, while also attempting to mitigate some of the barriers to HTC like access and stigma.

The study uses a two-arm post-test only randomized cluster design, with eight pair-matched health centers in two districts randomly assigned to intervention or control arm. VHTs supported by health centers in the intervention arm receive classroom training and supervised practical experience in HTC. Supervision and commodity supply occur through health centers, building on support mechanisms for family planning. External quality assurance is conducted quarterly through health centers as part of program implementation. VHTs receive refresher training after 8 months. VHTs in the intervention arm provide both family planning and HTC services during the study period, and then return to providing family planning only at the end of the project. VHTs in the control arm only provide family planning. HTC and/or family planning services, as applicable, are available to all adults in the communities served by the VHTs.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• At least six months of experience providing family planning services, including injectable contraceptives
• Attached to one of the eight health centers selected for the study for supervision, commodity supply, and referral management
• All VHTs in the intervention group are trained in HTC service provision and interviewed as part of the evaluation. VHTs in the control group are not interviewed.

Services (family planning and/or HTC) are made available to all adults in VHTs' communities. Data collection involves a client survey. Inclusion criteria for participation in the survey are:

• Age 18 or more
• Female
• Revisit family planning clients of VHTs (will have received family planning services from the VHT more than once)
• Where this service is available, having received HTC from the VHT is not an eligibility criterion

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FP and HTC services	FP and HTC services	VHTs in the intervention arm provide both family planning and HTC services between May 2012 and September 2013, then return to providing family planning only at the end of the project. Services are made available to all adults in VHTs' communities. HIV testing is done using the national rapid testing algorithm. Clients who test positive for HIV are referred to a health center for care and treatment and receive disclosure support and information on peer support groups.
FP services	FP services	VHTs in the control arm only provide family planning services.

Primary Outcome Measures

Name	Time	Method
Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions	10 days

Secondary Outcome Measures

Name	Time	Method
HIV testing attitude scale derived from Likert-scale statements in the client survey	10 days

Trial Locations

Locations (1)

FHI360 Uganda; 🇺🇬 Kampala, Uganda