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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Enhanced linkage to care
* Behavioral: Standard-of-care plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Linkage<br>Participants 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. | Behavioral: Enhanced linkage to care<br> <br> |
| Active Comparator: Standard-of-care plus<br>Behavioral: Participants will receive the standard-of-care (paper-based referrals) plus return of CD4 test results to their home. | Behavioral: Standard-of-care plus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HIV Viral load | defined as HIV RNA <20 cells/ml collected via venous blood draw | 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Viral load Suppression | defined as HIV RNA <1000 cells/ml collected via venous blood draw | 12 months follow up | 
| Linkage to HIV care | Enrollment in an HIV clinic with a 2nd clinic visit | 6 and 12 months follow up | 
| Initiating ART | Percentage of eligible participants initiating ART | 6 and 12 months follow up | 
| Short-term retention on treatment | on ART at 6 and 12 month follow up: reporting taking ART at each follow-up | 6 and 12 months follow up | 
| Time to HIV care | Time from HIV testing to enrollment in an HIV clinic | 6 and 12 months follow up | 
| Time to receipt of ART | Time from HIV testing to receipt of ART | 6 and 12 months follow up | 
| 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 | 6 and 12 months follow up | 
| Short-term retention in care: Proportion of kept visits/scheduled visits | Proportion of kept visits/scheduled visits (kept + missed visits) | 6 and 12 months follow up | 
| 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 | 6 and 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention Studies, Access to Health Care, Social Stigma, Social Support