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

September 17, 2014 updated by: FHI 360
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • FHI360 Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: FP and HTC services
In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).
Active Comparator: FP services
VHTs in the control arm only provide family planning services.
Other: FP services
VHTs in the control arm only provide family planning services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV testing attitude scale derived from Likert-scale statements in the client survey
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

Ministry of Health, Uganda

Investigators

  • Principal Investigator: Aurélie Brunie, PhD, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 467637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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