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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02545673
• Date of registration: 31/08/2015
• Prospective Registration: Yes
• Primary sponsor: Susan M Kiene
• Public title: Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
• Scientific title: Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
• Date of first enrolment: November 24, 2015
• Target sample size: 567
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02545673
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Uganda

Contacts

• Name: Susan M. Kiene, PhD
• Affiliation: San Diego State University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 59 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Behavioral: Standard-of-care plus

Behavioral: Enhanced linkage to care

Primary Outcome(s)

Undetectable HIV Viral load [Time Frame: 12 months follow up]

Secondary Outcome(s)

Time to receipt of ART [Time Frame: 6 and 12 months follow up]

Short-term retention on treatment [Time Frame: 6 and 12 months follow up]

Short-term retention in care: 4 month visit constancy [Time Frame: 6 and 12 months follow up]

HIV Viral load Suppression [Time Frame: 12 months follow up]

Short-term retention in care: Missed visits [Time Frame: 6 and 12 months follow up]

Linkage to HIV care [Time Frame: 6 and 12 months follow up]

Initiating ART [Time Frame: 6 and 12 months follow up]

Time to HIV care [Time Frame: 6 and 12 months follow up]

Short-term retention in care: Proportion of kept visits/scheduled visits [Time Frame: 6 and 12 months follow up]

Secondary ID(s)

UG2015_01

R01MH106391

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Makerere University

University of Connecticut

Harvard School of Public Health (HSPH)

National Institute of Mental Health (NIMH)