HIV (Human Immunodeficiency Virus)
Conditions
Keywords
Antiretroviral Treatment Adherence, Conditional Cash Transfers, Tanzania, People Living With HIV, Behavioral Economics
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 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (\ $10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.
Interventions
BEHAVIORALConditional Cash Transfer
The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (\ $10) for up to 6 months conditional on visit attendance.
Sponsors
Health for a Prosperous Nation
Rasello
Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Facility staff will not be blinded to intervention assignment. However, all other research staff will be blinded to intervention assignment. In addition, participants will not be told during the consent process that as part of the study there are intervention and control clinics. The rationale for this is to prevent patients transferring from intervention to control clinics if they find out that there are some clinics offering cash transfers to new ART clients. Large numbers of transferring patients will compromise the integrity of the study and will create an undue burden for facility staff at intervention clinics.
Intervention model description
2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than or equal to 18 years of age * Living with HIV infection * Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study * Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone) * Do not intend to transfer to a different facility for HIV care within the following 12 months.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 after starting ART. 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 |
|---|---|---|
| Appointment Attendance | 12 months | The proportion of scheduled visits that were completed during the 0-12 month period |
| 6-month Viral Suppression | 6 month | the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. 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). |
| Proportion Virally Suppressed | 12 months | • The proportion virally suppressed (\<1000 copies/ml) of those PLHIV with a viral load result |
Countries
Tanzania
Outcome results
None listed