HIVNCT02711293
The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression
A study testing ART home delivery and Enhanced nutrition counseling in people with HIV and Community Health Workers, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial summary
Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Community Health Workers, Antiretroviral Therapy, Highly Active
- What is being tested?
- ART home delivery and Enhanced nutrition counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,172 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2016to Feb 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having attended one of the participating healthcare facilities for ART care during the enrolment period
- Living in a neighborhood that is in the healthcare facility's catchment area
Who cannot join
- ART patients who are pregnant at the time of enrollment
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression: A Non-inferiority Cluster-randomized Controlled Trial in Dar es Salaam, Tanzania
Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. The primary endpoint of this trial is the proportion of ART patients (regardless of whether they were clinically stable on ART at enrollment) who are in viral failure at the end of the study period. The non-inferiority design applies only to this primary endpoint. The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of 1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment area'). We matched all 48 healthcare facilities offering ART services and having affiliated public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.
- Being tested
- ART home delivery, Enhanced nutrition counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART home deliveryOther
Community health workers visit participants who are clinically stable on antiretroviral therapy (ART) at home (maintaining patients' prior clinic visit frequency) to deliver ART. Clinically stable on ART was defined as 1) taking ART for at least six months, 2) having had a CD4-cell count >350 cells/μL or a suppressed viral load at six or more months after ART initiation, and 3) the patient's most current CD4-cell count must have been >350 cells/μL or the most current viral load must have shown viral suppression, with the last measurement not taken more than 12 months ago.
Enhanced nutrition counselingOther
Community health workers visit participants at home to provide standard counseling (focusing on family planning, prevention of HIV transmission, and ART adherence) plus enhanced nutrition counseling (covering food production and dietary advice). In addition, participants who state that they have access to a plot of land or garden to grow vegetables receive a pack of seeds (amaranth, cowpea, or pumpkin) at enrolment.
| Study group | Role | What they receive |
|---|---|---|
| ART home delivery + enhanced nutrition counseling | Experimental | Community health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard plus enhanced nutrition counseling. Receives: Other: ART home delivery; Other: Enhanced nutrition counseling |
| ART home delivery + no enhanced nutrition counseling | Experimental | Community health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard counseling. Receives: Other: ART home delivery |
| No ART home delivery + enhanced nutrition counseling | Experimental | Community health workers visit participants at home to provide enhanced nutrition counseling. Participants will not receive ART home delivery. Receives: Other: Enhanced nutrition counseling |
| Standard of care | No intervention | Participants in this arm receive facility-based ART care and no enhanced nutrition counseling. They receive community health worker visits as per the standard of care in Dar es Salaam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants in viral failure, comparing participants that received the intervention (ART home delivery if stable on ART or standard facility-based care if unstable) versus those that received the standard of care.
Measured: At the end of the study period
The mean BMI of participants in clusters assigned to standard counseling by CHWs versus those in clusters assigned to standard plus enhanced nutrition counseling.
Measured: At the end of the study period
Secondary outcomes (5)
Participants' healthcare expenditures
Measured: In the last six months
Self-reported ART adherence
Measured: In the last one month
The proportion of patients with access to a plot of land who grow vegetables or fruits for their own consumption.
Measured: At the end of the study period
Diversity of dietary intake
Measured: At the end of the study period
The proportion of patients who are anemic
Measured: At the end of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionFeb 2018
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 HIVStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Management and Development for Health, International Initiative for Impact Evaluation
- Responsible party
- Principal investigator, Till Barnighausen, Harvard School of Public Health (HSPH)
- Investigators
- Till Bärnighausen, MD ScD, Principal investigator, Harvard School of Public Health (HSPH)Pascal Geldsetzer, MBChB MPH, Principal investigator, Harvard School of Public Health (HSPH)Nzovu Ulenga, MD, Principal investigator, Management and Development for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711293
- Sponsor's protocol ID
- RIDIE-STUDY-ID-562a718b12fa0
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geldsetzer P, Francis JM, Sando D, Asmus G, Lema IA, Mboggo E, Koda H, Lwezaula S, Ambikapathi R, Fawzi W, Ulenga N, Barnighausen T. Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2018 Sep 19;15(9):e1002659. doi: 10.1371/journal.pmed.1002659. eCollection 2018 Sep.
PubMed 30231024Geldsetzer P, Francis JM, Ulenga N, Sando D, Lema IA, Mboggo E, Vaikath M, Koda H, Lwezaula S, Hu J, Noor RA, Olofin I, Larson E, Fawzi W, Barnighausen T. The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania. BMC Health Serv Res. 2017 Feb 22;17(1):160. doi: 10.1186/s12913-017-2032-7.
PubMed 28228134
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression: A Non-inferiority Cluster-randomized Controlled Trial in Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT02711293
- Acronym / sponsor ID
- RIDIE-STUDY-ID-562a718b12fa0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,172 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Management and Development for Health, International Initiative for Impact Evaluation
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Mar 2016 (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.
Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. The primary endpoint of this trial is the proportion of ART patients (regardless of whether they were clinically stable on ART at enrollment) who are in viral failure at the end of the study period. The non-inferiority design applies only to this primary endpoint. The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of 1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment area'). We matched all 48 healthcare facilities offering ART services and having affiliated public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART home delivery + enhanced nutrition counseling | Experimental | Other: ART home delivery, Other: Enhanced nutrition counselingCommunity health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard plus enhanced nutrition counseling. |
| ART home delivery + no enhanced nutrition counseling | Experimental | Other: ART home deliveryCommunity health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard counseling. |
| No ART home delivery + enhanced nutrition counseling | Experimental | Other: Enhanced nutrition counselingCommunity health workers visit participants at home to provide enhanced nutrition counseling. Participants will not receive ART home delivery. |
| Standard of care | No intervention | –Participants in this arm receive facility-based ART care and no enhanced nutrition counseling. They receive community health worker visits as per the standard of care in Dar es Salaam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having attended one of the participating healthcare facilities for ART care during the enrolment period
- Living in a neighborhood that is in the healthcare facility's catchment area
Key exclusion criteria (2 listed)
- ART patients who are pregnant at the time of enrollment
- Inability to provide written informed 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 |
|---|---|---|
| ART home deliveryCommunity health workers visit participants who are clinically stable on antiretroviral therapy (ART) at home (maintaining patients' prior clinic visit frequency) to deliver ART. Clinically stable on ART was defined as 1) taking ART for at least six months, 2) having had a CD4-cell count >350 cells/μL or a suppressed viral load at six or more months after ART initiation, and 3) the patient's most current CD4-cell count must have been >350 cells/μL or the most current viral load must have shown viral suppression, with the last measurement not taken more than 12 months ago. | Other | ART home delivery + enhanced nutrition counseling, ART home delivery + no enhanced nutrition counseling |
| Enhanced nutrition counselingCommunity health workers visit participants at home to provide standard counseling (focusing on family planning, prevention of HIV transmission, and ART adherence) plus enhanced nutrition counseling (covering food production and dietary advice). In addition, participants who state that they have access to a plot of land or garden to grow vegetables receive a pack of seeds (amaranth, cowpea, or pumpkin) at enrolment. | Other | ART home delivery + enhanced nutrition counseling, No ART home delivery + enhanced nutrition counseling |
Primary outcome
The proportion of participants in viral failure, comparing participants that received the intervention (ART home delivery if stable on ART or standard facility-based care if unstable) versus those that received the standard of care.
Time frame: At the end of the study period
The mean BMI of participants in clusters assigned to standard counseling by CHWs versus those in clusters assigned to standard plus enhanced nutrition counseling.
Time frame: At the end of the study period
5 secondary outcomes
Participants' healthcare expenditures
Time frame: In the last six months
Self-reported ART adherence
Time frame: In the last one month
The proportion of patients with access to a plot of land who grow vegetables or fruits for their own consumption.
Time frame: At the end of the study period
Diversity of dietary intake
Time frame: At the end of the study period
The proportion of patients who are anemic
Time frame: At the end of the study period
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 6 Mar 2018.
- Derived from this study: PubMed 30231024Geldsetzer P, Francis JM, Sando D, Asmus G, Lema IA, Mboggo E, Koda H, Lwezaula S, Ambikapathi R, Fawzi W, Ulenga N, Barnighausen T. Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2018 Sep 19;15(9):e1002659. doi: 10.1371/journal.pmed.1002659. eCollection 2018 Sep.
- Derived from this study: PubMed 28228134Geldsetzer P, Francis JM, Ulenga N, Sando D, Lema IA, Mboggo E, Vaikath M, Koda H, Lwezaula S, Hu J, Noor RA, Olofin I, Larson E, Fawzi W, Barnighausen T. The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania. BMC Health Serv Res. 2017 Feb 22;17(1):160. doi: 10.1186/s12913-017-2032-7.
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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.
Till Bärnighausen, MD ScD principal investigator
Harvard School of Public Health (HSPH)
Pascal Geldsetzer, MBChB MPH principal investigator
Harvard School of Public Health (HSPH)
Nzovu Ulenga, MD principal investigator
Management and Development for Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART home delivery and Enhanced nutrition counseling in people with HIV and Community Health Workers, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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: finished, as of the sponsor's last update on 6 Mar 2018. 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 Tanzania. 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?
The proportion of participants in viral failure, comparing participants that received the intervention (ART home delivery if stable on ART or standard facility-based care if unstable) versus those that received the standard of care. (time frame: At the end of the study period). The study lists 2 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 NCT02711293, 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 6 Mar 2018.