Clinical trial NCT02545673: Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
Official title: Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Intervention Studies
Access to Health Care
Social Stigma
Social Support
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Makerere University
name: University of Connecticut
name: Harvard School of Public Health (HSPH)
name: National Institute of Mental Health (NIMH)
First posted: 2015-09-10
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

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

Primary outcomes:
measure: Undetectable HIV Viral load
timeFrame: 12 months follow up
Secondary outcomes:
measure: HIV Viral load Suppression
timeFrame: 12 months follow up
measure: Linkage to HIV care
timeFrame: 6 and 12 months follow up
measure: Initiating ART
timeFrame: 6 and 12 months follow up
measure: Short-term retention on treatment
timeFrame: 6 and 12 months follow up
measure: Time to HIV care
timeFrame: 6 and 12 months follow up
measure: Time to receipt of ART
timeFrame: 6 and 12 months follow up
measure: Short-term retention in care: Missed visits
timeFrame: 6 and 12 months follow up
measure: Short-term retention in care: Proportion of kept visits/scheduled visits
timeFrame: 6 and 12 months follow up
measure: Short-term retention in care: 4 month visit constancy
timeFrame: 6 and 12 months follow up
Other outcomes:
measure: Receipt of co-trimoxazole
timeFrame: 6 and 12 months follow up
measure: Time to receipt of co-trimozazole
timeFrame: 6 and 12 months follow up
Locations:
city: Gombe
country: Uganda
facility: Butambala, Mpigi, Mityana, Gomba Districts
Study officials:
affiliation: San Diego State University
name: Susan M. Kiene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiene SM, Kalichman SC, Sileo KM, Menzies NA, Naigino R, Lin CD, Bateganya MH, Lule H, Wanyenze RK. Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/PATH cluster randomized controlled trial. BMC Infect Dis. 2017 Jul 3;17(1):460. doi: 10.1186/s12879-017-2537-z.