Advanced HIV DiseaseAHD-ZambiaNCT06904456
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
An observational study of Advanced HIV Disease, run by Boston University at 1 site in Zambia.
Trial summary
In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HIV Disease
- How many people
- 11,800 participants
- Where
- 1 siteZambia
- Study dates
- 22 Apr 2025to Jun 2027
- 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: Participants will be adult HIV treatment patients and providers at the study sites who meet inclusion and exclusion criteria for each cohort.
Who may be able to join
- ≥18 years old
- Presenting at a study site clinic for HIV diagnosis or care
- Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)
- Screened for AHD by clinic, prior to or within 1 month of ART initiation
- Written informed consent to participate
- ≥18 years old
Show all 19Show fewer
- Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site
- All inclusion criteria for the full cohort
- Initiated/re-initiated ART within the past 6 months
- Returns to the study site for a clinic visit during the study enrollment period
- Written informed consent to participate
- ≥18 years old
- Living with HIV
- Admitted for inpatient care related to AHD
- Initiated or re-initiated ART within the last 6 months
- Written informed consent to participate
- Employed by or at the study site for at least 6 months
- Directly interact with clients presenting with AHD
- Written informed consent to participate
Who cannot join
- Pregnant and/or presenting for antenatal care
- Too ill at the time of AHD screening and at the next clinic visit to participate in the study
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Cohort 2
- Pregnant and/or presenting for antenatal care as reported in records
- All exclusion criteria for the full cohort
Show all 16Show fewer
- Too ill at the time of study enrollment visit to participate in the study
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Been on ART >6 months
- Cohort 3
- Pregnant and/or presenting for antenatal care
- Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease.
- Cohort 4
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site, 1 recruiting
- Recruiting
CHAI-Zambia
Lusaka
Hilda Shakwelele, +260 97 9153318, hshakwelele@clintonhealthaccess.org
Thandiwe Ngoma
About this study
In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients, including how they are defined and diagnosed (e.g. low CD4 count v. clinical condition), their demographic and socioeconomic profiles, their HIV care histories, what services they receive, and their short-term outcomes (achieve viral suppression, remain AHD, disengage from care, die) and the timing of these outcomes.
The Retain6 project aims to improve HIV treatment outcomes during clients' first six months on ART, when disengagement from care and mortality are highest. This protocol, called Advanced HIV disease during the first six months on antiretroviral therapy in Zambia (AHD Zambia), describes an observational study that will describe the experiences of clients who are diagnosed with AHD upon ART initiation (or re-initiation) in Zambia. Data collected will include clinical and socioeconomic characteristics, clinical and non-clinical needs, services delivered and received, and clients' and providers' concerns and preferences. The study's overall goal is to provide information to the Zambia MOH, treatment program partners, providers, and other stakeholders to better understand who is presenting with AHD in Zambia, how they are currently managed, and their treatment outcomes after starting ART. This information will be useful in determining interventions and guideline changes that might improve short- and long-term outcomes for AHD patients.
The study, which will be conducted in collaboration with the Zambia MOH, will include retrospective file reviews, prospective quantitative surveys with outpatient and inpatient clients, qualitative focus group discussions (FGDs) and interviews with clients, and provider surveys and interviews.
- Conditions
- Advanced HIV Disease
- Keywords
- Antiretroviral therapy (ART), Zambia, Service delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Prospective cohort | Cohort 1 is a prospective cohort of adults screened for AHD during the approximately three-month data collection period of the AHD Zambia study. Clients will be enrolled into the study if they 1) are not on ART or have been on ART for up to one month, and 2) are screened for AHD on the day of study enrollment or, if missed on the day they are screened for AHD, will be enrolled at the next clinic visit within one month of AHD screening. Record review for up to 12 months before and 12 months after study enrollment. Baseline survey and qualitative follow up. | |
| 2. Hybrid cohort | Cohort 2 is a hybrid cohort of all adult HIV clients recorded in study sites' AHD screening registers, improvised registers, and/or clinic records as having been screened for AHD at or before ART initiation in the 12 months preceding the start of Cohort 1 data collection. Electronic and paper medical record data will be collected for all of Cohort 2 for the 12 months before and 12 months after the AHD screening date. A subset of Cohort 2 respondents-those who return to the study sites for a clinic visit during the data collection period-will be invited to consent and participate in a quantitative survey and in follow-up qualitative interviews, similar to Cohort 1 enrollees. | |
| 3. Inpatient cohort | Cohort 3 includes adult HIV clients admitted in a study health facility for AHD management. Under the Zambia Ministry of Health's "hub and spoke model" for AHD management, AHD patients requiring hospitalization are admitted to hub facilities. Of the 24 study facilities in AHD-Zambia, 8 are hubs that admit AHD patients. The remaining 16 study sites refer AHD clients requiring admission to the nearest hospital. We will enroll Cohort 3 only at the 8 sites that offer inpatient admission for AHD. | |
| 4. Provider cohort | At each study site, we will ask the facility manager to refer us to up to 5 staff who provide care for AHD clients and represent different cadres. This may include doctors and clinical officers, nurses, counselors, and pharmacists, though we anticipate the majority of respondents to be doctors, nurses and clinical officers, who provide most HIV care in Zambia. Each cohort participant will be administered a one-time survey regarding AHD care at the facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation characteristics
Characteristics of clients presenting with AHD at treatment initiation or re-initiation, compared to clients screened but found not to have AHD.
Measured: 6 months
Inpatient characteristics
Characteristics of clients admitted to hospital after an AHD diagnosis.
Measured: 6 months
Six-month retention
Retention in care of clients presenting with AHD at 6 months after AHD diagnosis.
Measured: 6 months
Six-month viral suppression
Viral suppression of clients presenting with AHD at 6 months after AHD diagnosis.
Measured: 6 months
Secondary outcomes (4)
12-month retention
Retention in care of clients presenting with AHD at 12 months after AHD diagnosis.
Measured: 12 months
12-month viral suppression
Viral suppression of clients presenting with AHD at 12 months after AHD diagnosis.
Measured: 12 months
Guideline fidelity
Facility and provider fidelity to Zambia's AHD guidelines
Measured: 12 months
Costs
Costs of resources used to provide AHD 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 posted1 Apr 2025
- Study start22 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced HIV DiseaseStudies 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
- 11,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Clinton Health Access Initiative Inc., Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Thandiwe Ngoma, Principal investigator, CHAI-Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904456
- Sponsor's protocol ID
- H-45653
- Other IDs
- INV-031690
- Acronym
- AHD-Zambia
- Status last verified
- May 2026
- First submitted
- 23 Mar 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymized data generated by the study, such as survey responses and qualitative data (not routine medical record data, which will not be owned by the study team), will be posted to a public data repository after final closure of the study protocol.
Publications
Ngoma T, Kamanga A, Scott N, Morgan A, Reddy Marri A, Makwalu T, Mulenga L, Sivile S, Benade M, Haimbe P, Shakwelele H, Rosen S. Advanced HIV disease during the first six months on antiretroviral therapy in Zambia: research protocol for a prospective, observational, multi-cohort study. Gates Open Res. 2025 Aug 27;9:66. doi: 10.12688/gatesopenres.16359.1. eCollection 2025.
PubMed 40896557
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
- ClinicalTrials.gov ID
- NCT06904456
- Acronym / sponsor ID
- AHD-Zambia / H-45653
- Conditions
- Advanced HIV Disease
- Keywords
- Antiretroviral therapy (ART), Zambia, Service delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,800 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Clinton Health Access Initiative Inc., Bill and Melinda Gates Foundation
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Apr 2025 (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.
In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients, including how they are defined and diagnosed (e.g. low CD4 count v. clinical condition), their demographic and socioeconomic profiles, their HIV care histories, what services they receive, and their short-term outcomes (achieve viral suppression, remain AHD, disengage from care, die) and the timing of these outcomes.
The Retain6 project aims to improve HIV treatment outcomes during clients' first six months on ART, when disengagement from care and mortality are highest. This protocol, called Advanced HIV disease during the first six months on antiretroviral therapy in Zambia (AHD Zambia), describes an observational study that will describe the experiences of clients who are diagnosed with AHD upon ART initiation (or re-initiation) in Zambia. Data collected will include clinical and socioeconomic characteristics, clinical and non-clinical needs, services delivered and received, and clients' and providers' concerns and preferences. The study's overall goal is to provide information to the Zambia MOH, treatment program partners, providers, and other stakeholders to better understand who is presenting with AHD in Zambia, how they are currently managed, and their treatment outcomes after starting ART. This information will be useful in determining interventions and guideline changes that might improve short- and long-term outcomes for AHD patients.
The study, which will be conducted in collaboration with the Zambia MOH, will include retrospective file reviews, prospective quantitative surveys with outpatient and inpatient clients, qualitative focus group discussions (FGDs) and interviews with clients, and provider surveys and interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Prospective cohort | – | –Cohort 1 is a prospective cohort of adults screened for AHD during the approximately three-month data collection period of the AHD Zambia study. Clients will be enrolled into the study if they 1) are not on ART or have been on ART for up to one month, and 2) are screened for AHD on the day of study enrollment or, if missed on the day they are screened for AHD, will be enrolled at the next clinic visit within one month of AHD screening. Record review for up to 12 months before and 12 months after study enrollment. Baseline survey and qualitative follow up. |
| 2. Hybrid cohort | – | –Cohort 2 is a hybrid cohort of all adult HIV clients recorded in study sites' AHD screening registers, improvised registers, and/or clinic records as having been screened for AHD at or before ART initiation in the 12 months preceding the start of Cohort 1 data collection. Electronic and paper medical record data will be collected for all of Cohort 2 for the 12 months before and 12 months after the AHD screening date. A subset of Cohort 2 respondents-those who return to the study sites for a clinic visit during the data collection period-will be invited to consent and participate in a quantitative survey and in follow-up qualitative interviews, similar to Cohort 1 enrollees. |
| 3. Inpatient cohort | – | –Cohort 3 includes adult HIV clients admitted in a study health facility for AHD management. Under the Zambia Ministry of Health's "hub and spoke model" for AHD management, AHD patients requiring hospitalization are admitted to hub facilities. Of the 24 study facilities in AHD-Zambia, 8 are hubs that admit AHD patients. The remaining 16 study sites refer AHD clients requiring admission to the nearest hospital. We will enroll Cohort 3 only at the 8 sites that offer inpatient admission for AHD. |
| 4. Provider cohort | – | –At each study site, we will ask the facility manager to refer us to up to 5 staff who provide care for AHD clients and represent different cadres. This may include doctors and clinical officers, nurses, counselors, and pharmacists, though we anticipate the majority of respondents to be doctors, nurses and clinical officers, who provide most HIV care in Zambia. Each cohort participant will be administered a one-time survey regarding AHD care at the facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adult HIV treatment patients and providers at the study sites who meet inclusion and exclusion criteria for each cohort.
Key inclusion criteria (19 listed)
- ≥18 years old
- Presenting at a study site clinic for HIV diagnosis or care
- Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)
- Screened for AHD by clinic, prior to or within 1 month of ART initiation
- Written informed consent to participate
Key exclusion criteria (16 listed)
- Pregnant and/or presenting for antenatal care
- Too ill at the time of AHD screening and at the next clinic visit to participate in the study
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Cohort 2
- Pregnant and/or presenting for antenatal care as reported in records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Initiation characteristics
Time frame: 6 months
Characteristics of clients presenting with AHD at treatment initiation or re-initiation, compared to clients screened but found not to have AHD.
Inpatient characteristics
Time frame: 6 months
Characteristics of clients admitted to hospital after an AHD diagnosis.
Six-month retention
Time frame: 6 months
Retention in care of clients presenting with AHD at 6 months after AHD diagnosis.
Six-month viral suppression
Time frame: 6 months
Viral suppression of clients presenting with AHD at 6 months after AHD diagnosis.
4 secondary outcomes
12-month retention
Time frame: 12 months
12-month viral suppression
Time frame: 12 months
Guideline fidelity
Time frame: 12 months
Costs
Time frame: 12 months
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 27 May 2026.
- Derived from this study: PubMed 40896557Ngoma T, Kamanga A, Scott N, Morgan A, Reddy Marri A, Makwalu T, Mulenga L, Sivile S, Benade M, Haimbe P, Shakwelele H, Rosen S. Advanced HIV disease during the first six months on antiretroviral therapy in Zambia: research protocol for a prospective, observational, multi-cohort study. Gates Open Res. 2025 Aug 27;9:66. doi: 10.12688/gatesopenres.16359.1. eCollection 2025.
- repository for study publications and reportsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Fully anonymized data generated by the study, such as survey responses and qualitative data (not routine medical record data, which will not be owned by the study team), will be posted to a public data repository after final closure of the study protocol.
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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.
Thandiwe Ngoma principal investigator
CHAI-Zambia
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 Advanced HIV Disease, run by Boston University 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 19 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?
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?
Contact Sydney Rosen, MPA ((857) 207-7909, sbrosen@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation characteristics (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT06904456, which also lists 1 linked publication.
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 27 May 2026.