HIV Testing and CounselingNCT02244398
Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda
A study testing FP and HTC services and FP services in people with HIV Testing and Counseling, run by FHI 360 at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Testing and Counseling
- What is being tested?
- FP and HTC services and FP services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Testing and Counseling
- Being tested
- FP and HTC services, FP services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP and HTC servicesOther
In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).
FP servicesOther
VHTs in the control arm only provide family planning services
| Study group | Role | What they receive |
|---|---|---|
| FP and HTC services | Experimental | 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. Receives: Other: FP and HTC services |
| FP services | Active comparator | VHTs in the control arm only provide family planning services. Receives: Other: FP services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions
Measured: 10 days
Secondary outcomes (1)
HIV testing attitude scale derived from Likert-scale statements in the client survey
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV Testing and CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Responsible party
- Sponsor
- Investigators
- Aurélie Brunie, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244398
- Sponsor's protocol ID
- 467637
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29624942Brunie 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.
PubMed 27045002
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda
- ClinicalTrials.gov ID
- NCT02244398
- Acronym / sponsor ID
- 467637
- Conditions
- HIV Testing and Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FP and HTC services | Experimental | Other: FP and HTC servicesVHTs 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 | Active comparator | Other: FP servicesVHTs in the control arm only provide family planning services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP and HTC servicesIn this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC). | Other | FP and HTC services |
| FP servicesVHTs in the control arm only provide family planning services | Other | FP services |
Primary outcome
Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions
Time frame: 10 days
1 secondary outcome
HIV testing attitude scale derived from Likert-scale statements in the client survey
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
- Derived from this study: PubMed 29624942Brunie 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.
- Derived from this study: PubMed 27045002Brunie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie Brunie, PhD principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FP and HTC services and FP services in people with HIV Testing and Counseling, run by FHI 360 at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.