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Completed

NCT Number: NCT02545673

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butambala, Mpigi, Mityana, Gomba Districts

Gombe, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion/Exclusion for home-based HIV counseling and testing and brief baseline questionnaire:

Inclusion criteria

  • 18-59 years of age or an emancipated minor

Exclusion criteria

  • not a resident of the household
  • Does not speak Luganda or English

Inclusion/Exclusion for the Intervention Study:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Enhanced linkage to care

Behavioral

Standard-of-care plus

Behavioral

Primary outcomes

  1. Undetectable HIV Viral load

    Time frame: 12 months follow up

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

Secondary outcomes

  1. HIV Viral load Suppression

    Time frame: 12 months follow up

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

  2. Linkage to HIV care

    Time frame: 6 and 12 months follow up

    Enrollment in an HIV clinic with a 2nd clinic visit

  3. Initiating ART

    Time frame: 6 and 12 months follow up

    Percentage of eligible participants initiating ART

  4. Short-term retention on treatment

    Time frame: 6 and 12 months follow up

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

  5. Time to HIV care

    Time frame: 6 and 12 months follow up

    Time from HIV testing to enrollment in an HIV clinic

  6. Time to receipt of ART

    Time frame: 6 and 12 months follow up

    Time from HIV testing to receipt of ART

  7. Short-term retention in care: Missed visits

    Time frame: 6 and 12 months follow up

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

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

    Time frame: 6 and 12 months follow up

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

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

    Time frame: 6 and 12 months follow up

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

Other outcomes

  1. Receipt of co-trimoxazole

    Time frame: 6 and 12 months follow up

    The percentage of participants who received co-trimoxazole

  2. Time to receipt of co-trimozazole

    Time frame: 6 and 12 months follow up

    Time to receipt of co-trimoxazole

Sponsors and collaborators

Lead sponsor

Susan M Kiene

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Makerere University
  • National Institute of Mental Health (NIMH)
  • University of Connecticut

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2015
Registry last updated
Nov 18, 2023

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.

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