HIV (Human Immunodeficiency Virus)
Conditions
Keywords
Conditional Cash Transfers, Tanzania, People Living With HIV
Brief 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.
Detailed 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
Interventions
BEHAVIORALConditional 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.
Sponsors
University of California, Berkeley
Health for a Prosperous Nation
Rasello
Ministry of Health, Tanzania
National Institute of Mental Health (NIMH)
Management and Development for Health (MDH), Tanzania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will not be told during the consent process that as part of the study there are intervention and control clinics. Laboratory staff analyzing viral load samples will be blind to intervention/control attribution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 6-month Viral Suppression | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 12-month Viral Suppression | 12 months | 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). |
| Number of Participants With 12-month Durable Viral Suppression | 12 months | 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) |
| Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months | 6 months | Number of scheduled visits that were completed during the 0-6 month period |
| Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months | 12 months | Number of scheduled visits attended between 0 and 12 months |
| Incidence of Mortality at 12-month | 12 months | The cumulative incidence of all-cause mortality at 12 months after study enrollment |
| Proportion of Participants Virally Suppressed Within 12-months | 12 months | Proportion of PLHIV with viral suppression in the 0-12-month follow-up period |
| Number of Participants at 12-months Re-linked to HIV Care | 12 months | Number of participants re-linked to to HIV care over 0 to 12 months, after study enrollment |
| Time to Re-linkage to HIV Care | 12 months | Time for patients to re-link back to HIV care |
| Number of Participants at 6-months Retained in Care | 6 months | The number 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) |
| Number of Participants at 12-months Retained in Care | 12 months | 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) |
Countries
Tanzania
Contacts
PRINCIPAL_INVESTIGATORJingshen Wang, PhD
University of California, Berkeley
PRINCIPAL_INVESTIGATORAmon Sabasaba, MD
Health for a Prosperous Nation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.93 years STANDARD_DEVIATION 11.53 |
| Attending HIV clinic closest to home | 421 Participants |
| Driving distance to major city | 91.8 kilometers STANDARD_DEVIATION 64.7 |
| Facility type Dispensary | 4 Cluster (Clinical sites) |
| Facility type Health Center | 9 Cluster (Clinical sites) |
| Facility type Hospital | 6 Cluster (Clinical sites) |
| Log average number of PLHIV on ART in all quarters in 2021 | 7.11 log(number of persons) STANDARD_DEVIATION 0.53 |
| Months since last missed appointment | 4.07 months STANDARD_DEVIATION 5.6 |
| Multidimensional poverty index Not poor but vulnerable to poverty | 108 Participants |
| Multidimensional poverty index Not poor/not vulnerable to poverty | 37 Participants |
| Multidimensional poverty index Poor/severely multidimensionally poor | 145 Participants |
| Overall perceived health rating (1-10) | 6.72 units on a scale STANDARD_DEVIATION 1.61 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region Geita | 16 Cluster (Clinical sites) |
| Region Kagera | 16 Cluster (Clinical sites) |
| Sex: Female, Male Female | 205 Participants |
| Sex: Female, Male Male | 112 Participants |
| Shared HIV status with at least one person | 294 Participants |
| WHO Clinical Stage at first visit back Stage 1 | 155 Participants |
| WHO Clinical Stage at first visit back Stage 2 | 56 Participants |
| WHO Clinical Stage at first visit back Stage 3 | 105 Participants |
| WHO Clinical Stage at first visit back Stage 4 | 26 Participants |
| Within 15 kilometers to major highway | 15 Cluster (Clinical sites) |
| Years on ART | 3.92 years STANDARD_DEVIATION 3.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 317 | 3 / 250 |
| other Total, other adverse events | 0 / 317 | 0 / 250 |
| serious Total, serious adverse events | 9 / 317 | 3 / 250 |
Outcome results
None listed