Clinical trial NCT02244398: Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda
Official title: Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Testing and Counseling
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Uganda
First posted: 2014-09-19
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions
timeFrame: 10 days
Secondary outcomes:
measure: HIV testing attitude scale derived from Likert-scale statements in the client survey
timeFrame: 10 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: FHI360 Uganda
Study officials:
affiliation: FHI 360
name: Aurélie Brunie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunie A, Mucheri PNW, Akol A, Chen M, Mercer SJ, Petruney T. Integrating Family Planning and HIV Services at the Community Level: Formative Assessment with Village Health Teams in Uganda. Afr J Reprod Health. 2017 Jun;21(2):73-80. doi: 10.29063/ajrh2017/v21i2.9.
citation: Brunie A, Wamala-Mucheri P, Akol A, Mercer S, Chen M. Expanding HIV testing and counselling into communities: Feasibility, acceptability, and effects of an integrated family planning/HTC service delivery model by Village Health Teams in Uganda. Health Policy Plan. 2016 Oct;31(8):1050-7. doi: 10.1093/heapol/czw035. Epub 2016 Apr 4.