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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545673
• Other study ID #: UG2015_01
• Secondary ID: R01MH106391
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 home-based HIV counseling and testing (HBHCT) in rural Uganda.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: October 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Enhanced linkage to care

• Standard-of-care plus

Locations

Country	Name	City	State
Uganda	Butambala, Mpigi, Mityana, Gomba Districts	Gombe

Sponsors (5)

Lead Sponsor	Collaborator
Susan M Kiene	Harvard School of Public Health (HSPH), Makerere University, National Institute of Mental Health (NIMH), University of Connecticut

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Receipt of co-trimoxazole	The percentage of participants who received co-trimoxazole	6 and 12 months follow up
Other	Time to receipt of co-trimozazole	Time to receipt of co-trimoxazole	6 and 12 months follow up
Primary	Undetectable HIV Viral load	defined as HIV RNA <20 cells/ml collected via venous blood draw	12 months follow up
Secondary	HIV Viral load Suppression	defined as HIV RNA <1000 cells/ml collected via venous blood draw	12 months follow up
Secondary	Linkage to HIV care	Enrollment in an HIV clinic with a 2nd clinic visit	6 and 12 months follow up
Secondary	Initiating ART	Percentage of eligible participants initiating ART	6 and 12 months follow up
Secondary	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
Secondary	Time to HIV care	Time from HIV testing to enrollment in an HIV clinic	6 and 12 months follow up
Secondary	Time to receipt of ART	Time from HIV testing to receipt of ART	6 and 12 months follow up
Secondary	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
Secondary	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
Secondary	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