HIVNCT04468789
Evaluation of Six-month HIV Treatment Dispensing in South Africa
An observational study of HIV, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Six-month ARV dispensing
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Health Economics and Epidemiology Research Office
Johannesburg, Gauteng, 2193
About this study
Official title: Evaluation of the National Department of Health's Six-month Antiretroviral Treatment Dispensing Demonstration Pilot in Primary Health Care Clinics in the Context of the COVID-19 Pandemic and Response in South Africa
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).
Read the detailed description
The overall aims of this study are to assess the uptake and impact of six-month medication dispensing (6MMD) on HIV patients' treatment outcomes at public-sector clinics; estimate the costs of the intervention; and assess patients' and providers' perspectives on 6MMD. All implementation of the interventions and generation of data will be done by the National Department of Health and its support partners; this study will evaluate the outcomes.
The specific objectives of the evaluation are to:
Objective 1: Among HIV infected patients on antiretroviral therapy who are newly eligible for 6MMD, assess the uptake of 6MMD among eligible patients, stratified by repeat prescription refill strategy. Evaluation questions:
- What proportion of patients is eligible for 6MMD?
- What proportion of eligible patients choose to enrol in 6MMD?
- What proportion of enrolled patients receive more than one consecutive 6-month refill?
Objective 2: Is six-month dispensing non-inferior to standard of care (two- or three-month dispensing) in terms of retention in care and viral suppression? Evaluation questions:
- What is the effect of 6MMD on retention compared to standard of care for patients eligible for 6MMD?
- What is the effect of 6MMD on viral suppression within 6 and 12 months of intervention enrollment (intervention patients) or eligibility (comparison patients), compared to standard of care for patients eligible for 6MMD?
- What is the effect of 6MMD on retention and suppression among all ART patients in a clinic, regardless of whether they were eligible for or received 6MMD?
Objective 3: Is 6MMD more or less acceptable to patients and providers than standard of care? Evaluation questions:
- What factors influence patient choice to enrol in 6MMD?
- To what extent does the risk of COVID-19 influence a patient's decision to enrol in 6MMD?
- What are the barriers and facilitators to implementing 6MMD from the perspective of providers?
- How has COVID-19 impacted the implementation of 6MMD?
- Has there been any task shifting as a result of the implementation of 6MMD?
- What was the level of fidelity to the standard operating procedures (SOP) for 6MMD implementation?
Objective 4: What is the cost of 6MMD to providers and patients compared to standard of care. Evaluation questions:
- How often do 6MMD patients return to facilities for HIV or other health care or to collect other chronic medications between scheduled ARV dispensing visits?
- What is the average cost to the provider (DOH) per 6MMD patient and for all ART patients at the study clinics?
- What is the patient cost of ART for those receiving 6MMD compared to standard of care?
- Conditions
- HIV
- Being tested
- Six-month ARV dispensing
- Keywords
- HIV, antiretroviral therapy, multi-month dispensing, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-month ARV dispensingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Six-month ARV dispensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of 6MMD
Proportion of patients eligible for 6 multi-month dispensing (6MMD) who enroll in 6MMD at intervention sites
Measured: Baseline
Retention in care
Proportion of patients eligible for 6MMD who are retained in care at 6 months
Measured: 6 months
Viral suppression
Proportion of patients eligible for 6MMD who are virally suppressed at 12 months
Measured: 12 months
Secondary outcomes (5)
Provider acceptability of 6MMD before intervention
Acceptability of 6MMD to healthcare providers, based on interview responses
Measured: Baseline
Provider acceptability of 6MMD after intervention
Acceptability of 6MMD to healthcare providers, based on interview responses
Measured: 6 months
Patient acceptability at baseline
Acceptability of 6MMD to patients, based on survey responses
Measured: Baseline
Patient acceptability at 6 months
Acceptability of 6MMD to patients, based on survey responses
Measured: 6 months
Provider costs
Costs to healthcare provider (study clinics) of 6MMD, compared to standard of care
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study startNov 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The South African government decided not to implement the pilot project for which this protocol was the evaluation. It was not approved by the IRB and never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Sydney Rosen, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468789
- Sponsor's protocol ID
- H-40512
- Other IDs
- OPP1192640
- Status last verified
- May 2021
- First submitted
- 8 Jul 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the National Department of Health's Six-month Antiretroviral Treatment Dispensing Demonstration Pilot in Primary Health Care Clinics in the Context of the COVID-19 Pandemic and Response in South Africa
- ClinicalTrials.gov ID
- NCT04468789
- Acronym / sponsor ID
- H-40512
- Conditions
- HIV
- Keywords
- HIV, antiretroviral therapy, multi-month dispensing, South Africa
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The South African government decided not to implement the pilot project for which this protocol was the evaluation. It was not approved by the IRB and never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa
- Study start
- Nov 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The overall aims of this study are to assess the uptake and impact of six-month medication dispensing (6MMD) on HIV patients' treatment outcomes at public-sector clinics; estimate the costs of the intervention; and assess patients' and providers' perspectives on 6MMD. All implementation of the interventions and generation of data will be done by the National Department of Health and its support partners; this study will evaluate the outcomes.
The specific objectives of the evaluation are to:
Objective 1: Among HIV infected patients on antiretroviral therapy who are newly eligible for 6MMD, assess the uptake of 6MMD among eligible patients, stratified by repeat prescription refill strategy. Evaluation questions:
- What proportion of patients is eligible for 6MMD?
- What proportion of eligible patients choose to enrol in 6MMD?
- What proportion of enrolled patients receive more than one consecutive 6-month refill?
Objective 2: Is six-month dispensing non-inferior to standard of care (two- or three-month dispensing) in terms of retention in care and viral suppression? Evaluation questions:
- What is the effect of 6MMD on retention compared to standard of care for patients eligible for 6MMD?
- What is the effect of 6MMD on viral suppression within 6 and 12 months of intervention enrollment (intervention patients) or eligibility (comparison patients), compared to standard of care for patients eligible for 6MMD?
- What is the effect of 6MMD on retention and suppression among all ART patients in a clinic, regardless of whether they were eligible for or received 6MMD?
Objective 3: Is 6MMD more or less acceptable to patients and providers than standard of care? Evaluation questions:
- What factors influence patient choice to enrol in 6MMD?
- To what extent does the risk of COVID-19 influence a patient's decision to enrol in 6MMD?
- What are the barriers and facilitators to implementing 6MMD from the perspective of providers?
- How has COVID-19 impacted the implementation of 6MMD?
- Has there been any task shifting as a result of the implementation of 6MMD?
- What was the level of fidelity to the standard operating procedures (SOP) for 6MMD implementation?
Objective 4: What is the cost of 6MMD to providers and patients compared to standard of care. Evaluation questions:
- How often do 6MMD patients return to facilities for HIV or other health care or to collect other chronic medications between scheduled ARV dispensing visits?
- What is the average cost to the provider (DOH) per 6MMD patient and for all ART patients at the study clinics?
- What is the patient cost of ART for those receiving 6MMD compared to standard of care?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | – | –Patients eligible for six-month dispensing receiving care at comparison sites. |
| Intervention group | – | Other: Six-month ARV dispensingPatients eligible for six-month dispensing receiving care at intervention sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six-month ARV dispensingPatients 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. | Other | Intervention group |
Primary outcome
Uptake of 6MMD
Time frame: Baseline
Proportion of patients eligible for 6 multi-month dispensing (6MMD) who enroll in 6MMD at intervention sites
Retention in care
Time frame: 6 months
Proportion of patients eligible for 6MMD who are retained in care at 6 months
Viral suppression
Time frame: 12 months
Proportion of patients eligible for 6MMD who are virally suppressed at 12 months
5 secondary outcomes
Provider acceptability of 6MMD before intervention
Time frame: Baseline
Provider acceptability of 6MMD after intervention
Time frame: 6 months
Patient acceptability at baseline
Time frame: Baseline
Patient acceptability at 6 months
Time frame: 6 months
Provider costs
Time frame: 12-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Rosen principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of 6MMD (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.