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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02545673
Enrollment
567
Registered
2015-09-10
Start date
2015-11-24
Completion date
2021-10-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Intervention Studies, Access to Health Care, Social Stigma, Social Support

Brief 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.

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.

Interventions

BEHAVIORALStandard-of-care plus

Sponsors

Makerere University
CollaboratorOTHER
University of Connecticut
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Susan M Kiene
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Undetectable HIV Viral load12 months follow updefined as HIV RNA \<20 cells/ml collected via venous blood draw

Secondary

MeasureTime frameDescription
HIV Viral load Suppression12 months follow updefined as HIV RNA \<1000 cells/ml collected via venous blood draw
Linkage to HIV care6 and 12 months follow upEnrollment in an HIV clinic with a 2nd clinic visit
Initiating ART6 and 12 months follow upPercentage of eligible participants initiating ART
Short-term retention on treatment6 and 12 months follow upon ART at 6 and 12 month follow up: reporting taking ART at each follow-up
Time to HIV care6 and 12 months follow upTime from HIV testing to enrollment in an HIV clinic
Short-term retention in care: Proportion of kept visits/scheduled visits6 and 12 months follow upProportion of kept visits/scheduled visits (kept + missed visits)
Short-term retention in care: 4 month visit constancy6 and 12 months follow up4-month constancy 4 month visit constancy: number of 4-month intervals with at least 1 kept visit
Time to receipt of ART6 and 12 months follow upTime from HIV testing to receipt of ART
Short-term retention in care: Missed visits6 and 12 months follow upMissed visit count: number of missed visits accrued (count measure) based on scheduled visits determined by Ministry of Health clinical guidelines

Other

MeasureTime frameDescription
Receipt of co-trimoxazole6 and 12 months follow upThe percentage of participants who received co-trimoxazole
Time to receipt of co-trimozazole6 and 12 months follow upTime to receipt of co-trimoxazole

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026