Rudi Kundini, Pamoja Kundini: Phase I (RKPK: Phase I)

University of California (UC), Berkeley

Status: Completed

Conditions: HIV (Human Immunodeficiency Virus)

Treatments: Behavioral: Conditional Cash Transfer

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05248100

R01MH125746 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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567 participants in 2 patient groups

Conditional Cash Transfer

Experimental group

Description:

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 Tanzanian Shillings (TSH) (\~$10), 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.

Treatment:

Behavioral: Conditional Cash Transfer

Control

No Intervention group

Description:

Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services.