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

HIV Testing and Counseling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244398
• Other study ID #: 467637
• Status: Completed
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 17, 2014
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Makerere University's School of Medicine Research and Ethics CommitteeUganda: Uganda National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Testing and Counseling

Intervention

Other:
• FP and HTC services
In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).
• FP services
VHTs in the control arm only provide family planning services

Locations

Country	Name	City	State
Uganda	FHI360 Uganda	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Ministry of Health, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions		10 days	No
Secondary	HIV testing attitude scale derived from Likert-scale statements in the client survey		10 days	No