Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
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|ClinicalTrials.gov Identifier: NCT02545673|
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2015
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Enhanced linkage to care Behavioral: Standard-of-care plus||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||566 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda|
|Actual Study Start Date :||November 24, 2015|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||May 15, 2021|
Experimental: Enhanced Linkage
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
Active Comparator: Standard-of-care plus
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
- HIV Viral load suppression [ Time Frame: 12 months follow up ]defined as HIV RNA <20 cells/ml) collected via venous blood draw
- Linkage to HIV care [ Time Frame: 6 and 12 months follow up ]Enrollment in an HIV clinic with a 2nd clinic visit
- Time to HIV care [ Time Frame: 6 and 12 months follow up ]Time from HIV testing to enrollment in an HIV clinic
- Receipt of co-trimoxazole [ Time Frame: 6 and 12 months follow up ]The percentage of participants who received co-trimoxazole
- Time to receipt of co-trimozazole [ Time Frame: 6 and 12 months follow up ]Time to receipt of co-trimoxazole
- Receipt of ART [ Time Frame: 6 and 12 months follow up ]Percentage of eligible participants receiving ART
- Time to receipt of ART [ Time Frame: 6 and 12 months follow up ]Time from HIV testing to receipt of ART
- 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
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545673
|Butambala, Mpigi, Mityana, Gomba Districts|
|Principal Investigator:||Susan M. Kiene, PhD||San Diego State University|