Rudi Kundini, Pamoja Kundini

HIV (Human Immunodeficiency Virus) Clinical Trial

— RKPK: Phase II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373095
• Other study ID #: R01MH125746 - Phase II
• Secondary ID: R01MH125746
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of California, Berkeley
• Contact: Sandra I McCoy, PhD, MPH
• Phone: +15106420513
• Email: smccoy[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 692
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PKC (adapted adherence counseling) and Conditional Cash Transfers
The intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically <$1.

Locations

Country	Name	City	State
Tanzania	Geita Regional Referral Hospital	Geita
Tanzania	Geita Town Council Hospital	Geita
Tanzania	Nyankumbu Health Center	Geita
Tanzania	Katoro Health Center	Katoro

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	12-Month Viral Suppression	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 12 months after study enrollment.	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
Secondary	12-month durable viral load	Proportion with durable HIV viral suppression 12 months after enrollment: at least 2 viral load measurements taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment and all are undetectable (<1000 copies/ml) will have met criteria for durable viral suppression at 12 months.	12 months
Secondary	12-month Appointment Attendance	The proportion of scheduled visits that were completed during the 0-12 month period	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 Mortality	The cumulative incidence of mortality at 12 months after study enrollment	12 months
Secondary	6-month Predictive value positive (PVP) of machine learning algorithm	Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 6 months	6 months
Secondary	12-month Predictive value positive (PVP) of machine learning algorithm	Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 12 months	12 months
Secondary	6-month PVP of routine clinical criteria	PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 6 months	6 months
Secondary	12-month PVP of routine clinical criteria	PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 12 months	12 months
Secondary	6-month Predictive value negative (PVN) of the machine learning algorithm	Predictive value negative (PVN) of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 6 months	6 months
Secondary	12-month PVN of the machine learning algorithm	PVN of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 12 months	12 months
Secondary	6-month PVN of routine clinical criteria	PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 6 months	6 months
Secondary	12-month PVN of routine clinical criteria	PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 12 months	12 months
Secondary	Enhanced Adherence Counseling Session Attendance	Proportion of enhanced adherence counseling sessions completed among sessions scheduled	6 months
Secondary	Viral Suppression with enhanced adherence counseling completion	Proportion with HIV viral suppression after completion of enhanced adherence counseling sessions	6 months
Secondary	6-Month Viral Suppression (<1000 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 6 months after study enrollment.	6 months
Secondary	6-Month Viral Suppression (<50 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 6 months after study enrollment.	6 months
Secondary	12-Month Viral Suppression (<50 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 12 months after study enrollment.	12 months