Evaluation of Six-month HIV Treatment Dispensing in South Africa

NCT04468789 | Withdrawn

• 2 other identifiers: H-40512OPP1192640
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Many countries in sub-Saharan Africa are implementing a policy of six-month dispensing of antiretroviral (ARV) medications for HIV. Under the new guidelines, stable patients can receive a six-month supply of ARV medications at once, reducing the number of clinic visits required for medication refills. South Africa is considering this policy but has not yet adopted it and has requested evidence of its feasibility, effectiveness, and costs to the healthcare system and to patients. The decision on whether to implement a six-month dispensing policy has become urgent due to the SARS-Cov-2 epidemic, as clinic visits to refill prescriptions pose COVID-19 transmission risks to both patients and providers. To generate the required evidence, South Africa is implementing a pilot program that will allow for a cluster-randomized evaluation of 6-month dispensing. This protocol is for that evaluation. It aims to provide supporting evidence to inform future policy and procurement decisions by the National Department of Health (NDOH). All interventions will be conducted as part of routine care by Department of Health staff. In the pilot program, the NDOH will randomize 28 clinics in two provinces 1:1 to receive the six month dispensing intervention or continue standard of care, which currently allows for 2-3 month dispensing. The researchers will assess the patient outcomes of six month dispensing, administer a cross-sectional patient questionnaire, conduct semi-structured in-depth interviews with care providers and implementers, and estimate the costs to NDOH and to patients of six month dispensing. A maximum of 150,545 patients will be followed through their medical records and 400 patients and providers will be consented to be interviewed at baseline and after 6 months (total maximum sample size = 150,945).

Conditions

HIV

Keywords

HIV; antiretroviral therapy; multi-month dispensing; South Africa

Outcome Measures

Primary Outcomes (3)

• Uptake of 6MMD

  Proportion of patients eligible for 6 multi-month dispensing (6MMD) who enroll in 6MMD at intervention sites

  Baseline

• Retention in care

  Proportion of patients eligible for 6MMD who are retained in care at 6 months

  6 months

• Viral suppression

  Proportion of patients eligible for 6MMD who are virally suppressed at 12 months

  12 months

Secondary Outcomes (5)

• Provider acceptability of 6MMD before intervention

  Baseline

• Provider acceptability of 6MMD after intervention

  6 months

• Patient acceptability at baseline

  Baseline

• Patient acceptability at 6 months

  6 months

• Provider costs

  12-months

Study Arms (2)

Comparison group

Patients eligible for six-month dispensing receiving care at comparison sites.

Intervention group

Patients eligible for six-month dispensing receiving care at intervention sites.

Other: Six-month ARV dispensing

Interventions

Six-month ARV dispensing OTHER

Patients in the intervention group who meet eligibility criteria will receive a six-month supply of antiretroviral medications, rather than the standard of care supply which is typically 2-3 months.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Objective 1: All adult, HIV-positive patients who have initiated antiretroviral therapy at the study sites Objective 2: All adult, HIV-positive patients who have initiated antiretroviral therapy at the study sites Objective 3: Adult, HIV-positive adults eligible for six-month dispensing at the intervention sites; and providers at the intervention sites

You may qualify if:

• Objectives 1 and 2: On same ART treatment regimen for at least 6 months; most recent viral load taken in the past 6 months; and last viral load undetectable (\<50 copies/ml3)
• Objective 3: Patient at an intervention site who meets the eligibility criteria for 6MMD; or provider at an intervention site

You may not qualify if:

• Objectives 1 and 2: Not resident in the facility's catchment area; recorded intention to transfer care to a different facility within 12 months; or pregnant and eligible for PMTCT
• Objective 3: Not resident in the facility's catchment area; recorded intention to transfer care to a different facility within 12 months; pregnant and eligible for PMTCT; unable to communicate in one of the language into which the consent documents and questionnaire have been translated

Sponsors & Collaborators

• Boston University: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Health Economics and Epidemiology Research Office

Johannesburg, Gauteng, 2193, South Africa

Location

Study Officials

• Sydney Rosen

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 14, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)