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HIVNCT02545673

Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda

A study testing Enhanced linkage to care and Standard-of-care plus in people with HIV, run by Susan M Kiene at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness of a linkage to care intervention at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among people testing HIV positive during… Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
HIV
What is being tested?
Enhanced linkage to care and Standard-of-care plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
1 siteUganda
Study dates
24 Nov 2015to 31 Oct 2021
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 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18-59 years of age or an emancipated minor
  • participated in the baseline interview and home-based HIV counseling and testing,
  • newly diagnosed HIV positive in the home-based HIV counseling and testing or previously diagnosed but never linked to HIV care

Who cannot join

  • not a resident of the household
  • Does not speak Luganda or English
  • Other household members also newly diagnosed as HIV positive/previously diagnosed but never linked to care. Only one person per household will be eligible to enroll

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Butambala, Mpigi, Mityana, Gomba Districts

    Gombe

Other trials in Uganda

About this study

The purpose of this study is to evaluate the effectiveness of a linkage to care intervention at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural Uganda.

Read the detailed description

Throughout sub-Saharan Africa there is a pressing need to facilitate early and easier entry into HIV care and treatment; up to two-thirds of patients are lost to follow up between testing HIV positive and initiation of antiretroviral (ARV) treatment. Home-based HIV testing and counseling (HBHCT), which identifies those who are HIV positive at earlier disease stages than other testing approaches, is becoming a large component of many sub-Saharan African countries' HIV prevention programs, including Uganda's. Paper-based referral to care, sometimes adding follow-up home visits, is the most common linkage-to-care approach with HBHCT. Linkage to care may be challenging with HBHCT since the testing occurs in the home at a distance from a health facility. The investigators propose to test an intervention which enhances a linkage to care intervention tested in an urban Ugandan provider-initiated HIV testing setting and found to improve linkage to care. The aims of the project are: (1) In a cluster randomized trial compare the effectiveness of the enhanced linkage to care intervention vs. standard-of-care (paper based referrals) at achieving HIV viral suppression and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and ART initiation among those eligible for antiretroviral therapy (ART). (2) Using the standard-of-care group as a natural history control, collect longitudinal data on barriers to and facilitators of linkage to and retention in care and treatment and HIV viral suppression. (3) Estimate the cost-effectiveness of the intervention, as compared to standard-of-care, in terms of major study outcomes.

Participation in the full study will last 12 months. All participants will first undergo HBHCT, viral load and CD4 testing, and complete a brief questionnaire. Participants will then be randomly assigned to one of two study arms: the enhanced linkage to care intervention arm or the standard-of-care control arm. Participants in both study arms will participate in interviewer administered questionnaires at 6 months and 12 months follow-up, viral load and CD4 testing at 12 month follow-up, and will permit the research team to access their medical records to extract information about their health status and linkage to care. Participants in the intervention arm will also receive a series of counseling sessions with an HIV counselor taking place at the participant's home, clinic, and over the phone. These sessions will last approximately 30 minutes, and consist of counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support.

Conditions
HIV
Being tested
Enhanced linkage to care, Standard-of-care plus
Keywords
Intervention Studies, Access to Health Care, Social Stigma, Social Support
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced linkage to careBehavioural

  • Standard-of-care plusBehavioural

Study groups in NCT02545673
Study groupRoleWhat they receive
Enhanced LinkageExperimentalParticipants will receive the enhanced linkage to care Intervention. Behavioral: Enhanced linkage to care Intervention Multiple sessions will focus on providing orientation to the HIV care system, counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support. The approach is guided by the HIV Stigma Framework.
Receives: Behavioral: Enhanced linkage to care
Standard-of-care plusActive comparatorBehavioral: Participants will receive the standard-of-care (paper-based referrals) plus return of CD4 test results to their home.
Receives: Behavioral: Standard-of-care plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Undetectable HIV Viral load

    defined as HIV RNA <20 cells/ml collected via venous blood draw

    Measured: 12 months follow up

Secondary outcomes (9)

  1. HIV Viral load Suppression

    defined as HIV RNA <1000 cells/ml collected via venous blood draw

    Measured: 12 months follow up

  2. Linkage to HIV care

    Enrollment in an HIV clinic with a 2nd clinic visit

    Measured: 6 and 12 months follow up

  3. Initiating ART

    Percentage of eligible participants initiating ART

    Measured: 6 and 12 months follow up

  4. Short-term retention on treatment

    on ART at 6 and 12 month follow up: reporting taking ART at each follow-up

    Measured: 6 and 12 months follow up

  5. Time to HIV care

    Time from HIV testing to enrollment in an HIV clinic

    Measured: 6 and 12 months follow up

  6. Time to receipt of ART

    Time from HIV testing to receipt of ART

    Measured: 6 and 12 months follow up

  7. Short-term retention in care: Missed visits

    Missed visit count: number of missed visits accrued (count measure) based on scheduled visits determined by Ministry of Health clinical guidelines

    Measured: 6 and 12 months follow up

  8. Short-term retention in care: Proportion of kept visits/scheduled visits

    Proportion of kept visits/scheduled visits (kept + missed visits)

    Measured: 6 and 12 months follow up

  9. Short-term retention in care: 4 month visit constancy

    4-month constancy 4 month visit constancy: number of 4-month intervals with at least 1 kept visit

    Measured: 6 and 12 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study start24 Nov 2015
  3. Primary completion30 Sep 2021
  4. Study completion31 Oct 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545673
Sponsor's protocol ID
UG2015_01
Other IDs
R01MH106391
Status last verified
Nov 2023
First submitted
31 Aug 2015
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Deidentified data will be shared with researchers within study investigators' institutions and with other researchers upon reasonable request.

Publications

  • Kiene SM, Kalichman SC, Sileo KM, Menzies NA, Naigino R, Lin CD, Bateganya MH, Lule H, Wanyenze RK. Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/PATH cluster randomized controlled trial. BMC Infect Dis. 2017 Jul 3;17(1):460. doi: 10.1186/s12879-017-2537-z.

    PubMed 28673251

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced linkage to care and Standard-of-care plus in people with HIV, run by Susan M Kiene 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 3 inclusion and 3 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 18 Nov 2023. 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?

Undetectable HIV Viral load (time frame: 12 months follow up). 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 NCT02545673, which also lists 1 linked publication.

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 18 Nov 2023.

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