Rudi Kundini, Pamoja Kundini (RKPK: Phase II)

University of California (UC), Berkeley

Status: Active, not recruiting

Conditions: HIV (Human Immunodeficiency Virus)

Treatments: Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05373095

R01MH125746 (U.S. NIH Grant/Contract)

R01MH125746 - Phase II

Details and patient eligibility

About

This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).

Full description

This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care.

Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (>1000 copies/ml). Enhanced adherence counseling includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (<1000 copies/ml) at 12 months following study enrollment.

Enrollment: 692 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. PLHIV on ART;
2. Age 18 years or older;
3. Phone ownership OR consistent phone access;
4. Not already enrolled in/currently attending enhanced adherence counseling sessions at the facility
5. Living in Geita Region and intends to receive care at a study facility for the next 12 months;
6. Classified as "high-risk" for loss to follow-up (LTFU) from HIV care, and
7. Provides written informed consent for participation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

692 participants in 2 patient groups

Adapted Adherence Counseling (PKC) and Conditional Cash Transfers

Experimental group

Description:

Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV clinical services according Tanzania's National Guidelines for the Management of HIV as the comparison arm, which includes provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions adapted for study purposes (PKC sessions). Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. In addition to enhanced adherence counseling, intervention participants will receive the offer of a cash transfer paired with attendance at each of the three enhanced adherence counseling sessions. The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions.

Treatment:

Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers

Enhanced Adherence Counseling only for those who qualify

No Intervention group

Description:

Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of a detectable viral load result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required.