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OpenTrials
Completed

NCT Number: NCT02244398

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FHI360 Uganda

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FP and HTC services

Other

In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).

FP services

Other

VHTs in the control arm only provide family planning services

Primary outcomes

  1. Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions

    Time frame: 10 days

Secondary outcomes

  1. HIV testing attitude scale derived from Likert-scale statements in the client survey

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • Ministry of Health, Uganda

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.