Clinical trial NCT05248100: Rudi Kundini, Pamoja Kundini: Phase I
Official title: Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase I
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Keywords: Conditional Cash Transfers
Tanzania
People Living With HIV
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Health for a Prosperous Nation
name: Rasello
name: Management and Development for Health
name: Ministry of Health, Tanzania
name: National Institute of Mental Health (NIMH)
First posted: 2022-02-21
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (\<1000 copies/ml) at 6 months after study enrollment.

Detailed description: The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (\<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.

This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (\~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

Primary Endpoint:

1. Viral suppression (\<1000 copies/ml) at 6 months after enrollment

Secondary Endpoints:

1. Viral suppression at 12 months after enrollment
2. Durable viral suppression at 12 months after enrollment
3. Appointment attendance
4. Time to re-linkage to care
5. Mortality at 12 months after enrollment
6. Re-linkage to care at 12 months after enrollment
7. Retention at 6 and 12 months, defined as the proportion of PLHIV on antiretroviral therapy (ART) at 6 months after enrollment and 12 months after enrollment, respectively

Eligibility criteria: Inclusion Criteria:

1. PLHIV living in the catchment area of a study health facility;
2. Age 18 years or older;
3. Phone ownership OR phone consistent phone access;
4. Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
5. Has had a clinic appointment within the last 24 months, and
6. Provides written informed consent for participation

Primary outcomes:
measure: 6-month Viral Suppression
timeFrame: 6 months
Secondary outcomes:
measure: 12-month Viral Suppression
timeFrame: 12 months
measure: Durable 12-month Viral Suppression
timeFrame: 12 months
measure: 6-month Appointment Attendance
timeFrame: 6 months
measure: 12-month Appointment Attendance
timeFrame: 12 months
measure: 12-month Mortality
timeFrame: 12 months
measure: Incidence of viral suppression
timeFrame: 12 months
measure: Incidence of re-linkage to HIV care
timeFrame: 12 months
measure: Time to re-linkage to HIV care
timeFrame: 12 months
measure: 6 month retention in care
timeFrame: 6 months
measure: 12 month retention in care
timeFrame: 12 months
Other outcomes:
Locations:
city: Geita
country: Tanzania
facility: Geita Region
city: Kagera
country: Tanzania
facility: Kagera Region
Study officials:
affiliation: University of California, Berkeley
name: Sandra I McCoy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: