Rudi Kundini, Pamoja Kundini: Phase I

HIV (Human Immunodeficiency Virus) Clinical Trial

— RKPK: Phase I  

Official title:

Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase I

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05248100
• Other study ID #: R01MH125746
• Secondary ID: R01MH125746
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 567
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV (Human Immunodeficiency Virus)
• HIV Infections

Intervention

Behavioral:
• Conditional Cash Transfer
The intervention is a one-time cash transfer of 22,500 Tanzanian Shillings (~$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.

Locations

Country	Name	City	State
Tanzania	Geita Region	Geita
Tanzania	Kagera Region	Kagera

Sponsors (6)

Lead Sponsor	Collaborator
University of California, Berkeley	Health for a Prosperous Nation, Management and Development for Health, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH), Rasello

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Viral Suppression	The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (=1000 copies/ml).	6 months
Secondary	12-month Viral Suppression	The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, the World Health Organization (WHO) threshold for virologic failure in low- and middle-income countries (LMIC)) versus not on ART or viral failure (=1000 copies/ml).	12 months
Secondary	Durable 12-month Viral Suppression	The proportion of people living with HIV (PLHIV) with durable HIV viral suppression at 12 months after study enrollment months (either: 1) =2 assessments of viral load, taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment (the recommended timing of immunologic monitoring for stable PLHIV on ART with viral suppression), or 2) =3 assessments if baseline viral load is >1000 copies/ml (the recommended timing of immunologic monitoring mandates an additional follow-up assessment 3 months and again at 12 months)	12 months
Secondary	6-month Appointment Attendance	The proportion of scheduled visits that were completed during the 0-6 month period	6 months
Secondary	12-month Appointment Attendance	The proportion of scheduled visits that were completed during the 0-12 month period	12 months
Secondary	12-month Mortality	The cumulative incidence of mortality at 12 months after study enrollment	12 months
Secondary	Incidence of viral suppression	The cumulative incidence of mortality at 12 months after study enrollment	12 months
Secondary	Incidence of re-linkage to HIV care	The cumulative incidence of re-linkage to to HIV care at 12 months after study enrollment	12 months
Secondary	Time to re-linkage to HIV care	Time for patients to re-link back to HIV care	12 months
Secondary	6 month retention in care	The proportion of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for =28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)	6 months
Secondary	12 month retention in care	The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for =28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)	12 months