Clinical trial NCT05373095: Rudi Kundini, Pamoja Kundini
Official title: Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Keywords: Tanzania
Conditional Cash Transfers
People Living With HIV
Machine Learning
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: 2022-05-13
Enrollment: 692
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 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 12-Month Viral Suppression
timeFrame: 12 months
Secondary outcomes:
measure: 6-month retention in care
timeFrame: 6 months
measure: 12-month retention in care
timeFrame: 12 months
measure: 12-month durable viral load
timeFrame: 12 months
measure: 12-month Appointment Attendance
timeFrame: 12 months
measure: 6-month Appointment Attendance
timeFrame: 6 months
measure: 12-month Mortality
timeFrame: 12 months
measure: 6-month Predictive value positive (PVP) of machine learning algorithm
timeFrame: 6 months
measure: 12-month Predictive value positive (PVP) of machine learning algorithm
timeFrame: 12 months
measure: 6-month PVP of routine clinical criteria
timeFrame: 6 months
measure: 12-month PVP of routine clinical criteria
timeFrame: 12 months
measure: 6-month Predictive value negative (PVN) of the machine learning algorithm
timeFrame: 6 months
measure: 12-month PVN of the machine learning algorithm
timeFrame: 12 months
measure: 6-month PVN of routine clinical criteria
timeFrame: 6 months
measure: 12-month PVN of routine clinical criteria
timeFrame: 12 months
measure: Enhanced Adherence Counseling Session Attendance
timeFrame: 6 months
measure: Viral Suppression with enhanced adherence counseling completion
timeFrame: 6 months
measure: 6-Month Viral Suppression (<1000 copies/ml)
timeFrame: 6 months
measure: 6-Month Viral Suppression (<50 copies/ml)
timeFrame: 6 months
measure: 12-Month Viral Suppression (<50 copies/ml)
timeFrame: 12 months
Other outcomes:
Locations:
city: Geita
country: Tanzania
facility: Geita Regional Referral Hospital
city: Geita
country: Tanzania
facility: Geita Town Council Hospital
city: Geita
country: Tanzania
facility: Nyankumbu Health Center
city: Katoro
country: Tanzania
facility: Katoro Health Center
Study officials:
affiliation: University of California, Berkeley
name: Sandra I McCoy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: