HIV
Conditions
Keywords
HIV, linkage, retention
Brief summary
Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.
Detailed description
Design: Two-arm cluster site-randomized trial with a pre-post intervention two-sample design nested in the intervention arm. Study Population: The study population is any adult who tests HIV positive at the HIV counseling and testing points participating in this study. The study unit (SU), the level of randomization for the study, includes specific HIV counseling and testing points at primary health care clinics and the HIV care and treatment services located in the same health facility. A total of 10 SU will be included. Sample Size: A total of 2,250 adults from the 10 study units will be included in the study, 750 in the SOC arm, 750 receiving CIS without FI and 750 receiving CIS+FI. Participants will be enrolled and followed for 12 months after enrollment.
Interventions
OTHERPoint of care CD4+ after HIV diagnosis
Point of care (POC) CD4+ testing immediately following HIV diagnosis
OTHERAccelerated ART initiation
Accelerated ART initiation for eligible participants delivered by facility personnel
BEHAVIORALSMS appointment reminders
Cellular appointment reminders delivered by study personnel
OTHERNon-cash Financial Incentives
Non-cash Financial Incentives
Sponsors
United States Agency for International Development (USAID)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result * Agreeing to be referred to the HIV care services associated with the SU * Agreeing to provide locator information * Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database * Able to provide informed consent
Exclusion criteria
* Being pregnant at study enrollment * Planning on leaving the community where they currently reside in the next 12 months * Enrolled in HIV care in the past 6 months at any clinic * Initiated ART (for any duration) in the past 6 months at any clinic * Currently on ART * Does not speak or understand Portuguese or Xitswa/Matswa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. | 1 month and 12 months after testing | An increase in linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. Participants are considered to achieve this outcome if they successfully link to the SU HIV care services within 1 month of testing HIV positive as measured from the electronic patient-level database used at the HIV care clinic (EPTS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to linkage to care | 12 months | A decrease in the median time to linkage to care |
Other
| Measure | Time frame |
|---|---|
| Mortality rate 12 months after HIV diagnosis | 12 months |
| Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI | 12 months |
| Time from ART eligibility to ART initiation | 12 months |
| Proportion of patients reporting that interventions were highly acceptable | 12 months |
| Proportion of patients receiving POC CD4+ test, short message service (SMS) reminders, accelerated ART initiation (among those eligible based on POC CD4+ test result), and FI | 12 months |
| Proportion of participants with new WHO Stage III/IV event or hospitalization | 12 months |
Countries
Mozambique
Outcome results
None listed