HIVPREFER-ZambiaNCT05454852
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in Zambia
An observational study of HIV, run by Boston University at 2 sites in 2 countries.
Trial summary
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Survey and Focus group
- How many people
- 771 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Sep 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults who have initiated or re-initiated antiretroviral therapy for HIV within 6 months of study enrollment, including the same day.
Who may be able to join
- Living with HIV and on ART for 0-6 six months at the study site
- ≥ 18 years old (18 and older considered adult for research purposes in Zambia)
- Presented at the study site for routine HIV-related care
- Provide written informed consent to participate.
Who cannot join
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
- Unwilling to take the time required to complete the questionnaire on the day of consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6.
One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time.
This protocol is for the PREFER-Zambia study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-Zambia will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 12 healthcare facilities in Zambia. Results are expected to inform the design of better models of service delivery for the early treatment period.
- Conditions
- HIV
- Being tested
- Survey, Focus group
- Keywords
- HIV, antiretroviral treatment, differentiated service delivery, retention in care, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Interviewer-administered survey
Focus groupOther
Focus group for selected participants
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adult patients within 6 months of ART initiation or re-initiation Receives: Other: Survey; Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Not missing a scheduled clinical or medication pickup visit during the first 6 months after treatment initiation by more than 28 days.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start15 Sep 2022
- Primary completion31 May 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc., Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Sydney Rosen, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454852
- Sponsor's protocol ID
- H-42903
- Acronym
- PREFER-Zambia
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share anonymized data that are generated by the study. Medical record data will not belong to the study team.
Publications
Rosen S, Grimsrud A, Ehrenkranz P, Katz I. Models of service delivery for optimizing a patient's first six months on antiretroviral therapy for HIV: an applied research agenda. Gates Open Res. 2020 Jul 29;4:116. doi: 10.12688/gatesopenres.13159.1. eCollection 2020.
PubMed 32875281Maskew M, Ntjikelane V, Juntunen A, Scott N, Benade M, Sande L, Hasweeka P, Haimbe P, Lumano-Mulenga P, Shakewelele H, Mukumbwa-Mwenechanya M, Rosen S. Preferences for services in a patient's first six months on antiretroviral therapy for HIV in South Africa and Zambia (PREFER): research protocol for a prospective observational cohort study. Gates Open Res. 2024 Jan 9;7:119. doi: 10.12688/gatesopenres.14682.2. eCollection 2023.
PubMed 38343769Mutanda N, Morgan A, Kamanga A, Sande L, Ntjikelane V, Maskew M, Haimbe P, Lumano-Mulenga P, Rosen S, Scott N. Experiences and Preferences in Zambia and South Africa for Delivery of HIV Treatment During a Client's First Six Months: Results of the PREFER Study's Cross-Sectional Baseline Survey. AIDS Behav. 2025 Jun;29(6):1713-1728. doi: 10.1007/s10461-025-04640-y. Epub 2025 Feb 1.
PubMed 39891834
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in Zambia
- ClinicalTrials.gov ID
- NCT05454852
- Acronym / sponsor ID
- PREFER-Zambia / H-42903
- Conditions
- HIV
- Keywords
- HIV, antiretroviral treatment, differentiated service delivery, retention in care, Zambia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc., Bill and Melinda Gates Foundation
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jul 2022 (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.
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6.
One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time.
This protocol is for the PREFER-Zambia study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-Zambia will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 12 healthcare facilities in Zambia. Results are expected to inform the design of better models of service delivery for the early treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Survey, Other: Focus groupAdult patients within 6 months of ART initiation or re-initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have initiated or re-initiated antiretroviral therapy for HIV within 6 months of study enrollment, including the same day.
Key inclusion criteria (4 listed)
- Living with HIV and on ART for 0-6 six months at the study site
- ≥ 18 years old (18 and older considered adult for research purposes in Zambia)
- Presented at the study site for routine HIV-related care
- Provide written informed consent to participate.
Key exclusion criteria (3 listed)
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
- Unwilling to take the time required to complete the questionnaire on the day of consent
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 |
|---|---|---|
| SurveyInterviewer-administered survey | Other | Participants |
| Focus groupFocus group for selected participants | Other | Participants |
Primary outcome
Retention
Time frame: 6 months
Not missing a scheduled clinical or medication pickup visit during the first 6 months after treatment initiation by more than 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 32875281Rosen S, Grimsrud A, Ehrenkranz P, Katz I. Models of service delivery for optimizing a patient's first six months on antiretroviral therapy for HIV: an applied research agenda. Gates Open Res. 2020 Jul 29;4:116. doi: 10.12688/gatesopenres.13159.1. eCollection 2020.
- Background: PubMed 38343769Maskew M, Ntjikelane V, Juntunen A, Scott N, Benade M, Sande L, Hasweeka P, Haimbe P, Lumano-Mulenga P, Shakewelele H, Mukumbwa-Mwenechanya M, Rosen S. Preferences for services in a patient's first six months on antiretroviral therapy for HIV in South Africa and Zambia (PREFER): research protocol for a prospective observational cohort study. Gates Open Res. 2024 Jan 9;7:119. doi: 10.12688/gatesopenres.14682.2. eCollection 2023.
- Derived from this study: PubMed 39891834Mutanda N, Morgan A, Kamanga A, Sande L, Ntjikelane V, Maskew M, Haimbe P, Lumano-Mulenga P, Rosen S, Scott N. Experiences and Preferences in Zambia and South Africa for Delivery of HIV Treatment During a Client's First Six Months: Results of the PREFER Study's Cross-Sectional Baseline Survey. AIDS Behav. 2025 Jun;29(6):1713-1728. doi: 10.1007/s10461-025-04640-y. Epub 2025 Feb 1.
- Individual participant dataSharing planned: Undecided. Will share anonymized data that are generated by the study. Medical record data will not belong to the study team.
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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 study director
Boston University
2 sites in 2 countries: 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 2 sites in 2 countries.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Zambia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454852, which also lists 3 linked publications.
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 8 Jan 2026.