HIV
Conditions
Keywords
HIV, Care, Treatment, Retention, Implementation Science
Brief summary
The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.
Detailed description
Background: Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment. Study Design: Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone. Sample size: The study aims to enrol 2500 participants (i.e. 650 participants per arm). Setting: The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.
Interventions
OTHERPoint of care CD4 testing
Participants in this arm will receive POC CD4 testing using the PIMA™ CD4 test system. Results will be made available to the participant within 20 to 25 minutes, before the participant leaves the HCT room. Participants will be given a copy of their results, which will be affixed to their referral letter, and they will be educated on the meaning of the CD4 results in relation to their health. This session will only be performed once at the time of issuing POC CD4 results.
BEHAVIORALCare Facilitation
The goal of this intervention is to provide on-going counselling using a combination of motivational and strengths-based counselling approaches.This is a time limited intervention with a maximum of 5 client sessions over a 90-day period. Participants will also be transitioned out of the intervention upon successful entry into HIV care. Sessions will be done using both face-to-face and telephonic approaches, although the former is more preferred.
OTHERTransport support
The goal of this intervention is to address one of the most frequently noted structural barrier to entry-into-care in resource constrained settings: prohibitive distance or transport cost to reach a health facility.This is a time limited intervention with a maximum of 3 transport assists for healthcare visits over a 90-day period. Transport assistance is provided in the form of reimbursements to claims submitted by the participant after a self-reported HIV care clinic visits. Participants in this arm, receive their transport support through in-person collection or via cell phone transfer. Transport support amounts are standardised according to geographical area.
Sponsors
United States Agency for International Development (USAID)
Johns Hopkins University
London School of Hygiene and Tropical Medicine
University of Witwatersrand, South Africa
The Aurum Institute NPC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation
Exclusion criteria
* self-reported prior or current registration as an HIV patient at a healthcare facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to entry into HIV care | 90 days | To compare the time to entering HIV care in each intervention arm against the standard of care arm over a 90 day period from study enrolment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion entering care | 90 days | To compare the proportion of participants in each arm entering care by 90 days from study enrolment |
| Time to entry into HIV care | 180 days | To compare the time to entering HIV care in each intervention arm against the standard of care over a 180 day period from study enrolment. |
| Mortality | 6 and 12 months | To compare time to mortality from enrolment by arm over a 12 month period |
| Cost per additional participant entering into care | Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period | To evaluate the incremental cost effectiveness (cost per additional participant entering into care by 90 days) for each intervention arm compared to the standard-of-care |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to ART initiation | 90 days | To compare the proportion of cART-eligible patients who initiate cART within 90 days of study enrolment in each study arm. |
Countries
South Africa
Outcome results
None listed