HIV InfectionsNCT03025165
A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia
A study testing Community Adherence Clubs and Home-Based ART Delivery in people with HIV Infections, run by HIV Prevention Trials Network at 1 site in Zambia.
Trial summary
The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Community Adherence Clubs and Home-Based ART Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,526 participants
- Where
- 1 siteZambia
- Study dates
- 1 May 2017to 22 Jul 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.
Read the detailed description
The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.
- Conditions
- HIV Infections
- Being tested
- Community Adherence Clubs, Home-Based ART Delivery, Standard of Care
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Adherence ClubsOther
Provision of ART care in the community to a club of 20-25 HIV+ patients
Home-Based ART DeliveryOther
Provision of ART care to an individual at their home
Standard of CareOther
Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Community Adherence Clubs | Experimental | ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring Receives: Other: Community Adherence Clubs |
| Home-Based ART Delivery | Experimental | Individuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring Receives: Other: Home-Based ART Delivery |
| Standard of Care | Other | Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines.
Measured: One year after beginning participation in the program
Secondary outcomes (1)
Viral suppression at 24 months
Undetectable HIV viral load 24 months after entry into the models of care. This will be done as part of routine laboratory monitoring and measured using routine programmatic data.
Measured: Two years after beginning participation in the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,526 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mohammed Limbada, MBCHB, MScID, Principal investigator, Zambart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025165
- Sponsor's protocol ID
- HPTN 071c
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limbada M, Macleod D, Situmbeko V, Muhau E, Shibwela O, Chiti B, Floyd S, Schaap AJ, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) study team. Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial. Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.
PubMed 34843674Limbada M, Bwalya C, Macleod D, Floyd S, Schaap A, Situmbeko V, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.
PubMed 33430928
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia
- ClinicalTrials.gov ID
- NCT03025165
- Acronym / sponsor ID
- HPTN 071c
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,526 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 19 Jan 2017 (estimated)
- 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.
The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.
Detailed description
The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Adherence Clubs | Experimental | Other: Community Adherence ClubsART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring |
| Home-Based ART Delivery | Experimental | Other: Home-Based ART DeliveryIndividuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring |
| Standard of Care | Other | Other: Standard of CareDelivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Community Adherence ClubsProvision of ART care in the community to a club of 20-25 HIV+ patients | Other | Community Adherence Clubs |
| Home-Based ART DeliveryProvision of ART care to an individual at their home | Other | Home-Based ART Delivery |
| Standard of CareDelivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines. | Other | Standard of Care |
Primary outcome
Viral Suppression
Time frame: One year after beginning participation in the program
Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines.
1 secondary outcome
Viral suppression at 24 months
Time frame: Two years after beginning participation in the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 34843674Limbada M, Macleod D, Situmbeko V, Muhau E, Shibwela O, Chiti B, Floyd S, Schaap AJ, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) study team. Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial. Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.
- Derived from this study: PubMed 33430928Limbada M, Bwalya C, Macleod D, Floyd S, Schaap A, Situmbeko V, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.
- 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.
Mohammed Limbada, MBCHB, MScID principal investigator
Zambart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Adherence Clubs and Home-Based ART Delivery in people with HIV Infections, run by HIV Prevention Trials Network at 1 site in Zambia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Viral Suppression (time frame: One year after beginning participation in the program). 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 NCT03025165, which also lists 2 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 25 Mar 2025.