HIVPhase 2/3NCT02957799
Improving South African Government Workers' Capacities to Deliver HIV Interventions
A Phase 2/3 study testing Accountable Condition in people with HIV and Partner Violence, run by University of California, Los Angeles at 2 sites in South Africa.
Trial summary
The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Partner Violence, Malnutrition
- What is being tested?
- Accountable Condition
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 1 Jun 2017to Oct 2023
- Phase
- Phase 2/3
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mothers living in the catchment area
- Mothers not identified as psychotic or delusional based on the interviewer's judgment
- Mothers able to provide informed consent
Who cannot join
- Inability to give informed consent
- Inability to converse with the interviewer or the CHW
- Death of the mother or infant.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Stellenbosch University
Stellenbosch
Zithulele Hospital
Zithulele
About this study
Official title: A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.
Read the detailed description
Each dollar invested in maternal, child health (MCH) yields a nine-fold benefit. Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes, including when delivered by CHW in low and middle income countries (LMIC). However, when home visiting programs are scaled, they are not effective. Africa has particular challenges with broad implementation of effective interventions often associated with the poorly trained and poorly monitored health personnel, in this case, CHW who are perinatal home visitors.
The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in a successful randomized controlled trial (RCT) conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood - to avoid stigma and to address multiple challenges concurrently. The visits significantly improved maternal and child outcomes over three years. Based on these results, the Philani Intervention Model served as one model for re-engineering primary health care for 65,000 CHW in South Africa. The Mthatha Provincial Government has agreed for the Philani Program to train, monitor, and supervise their already-hired CHW. This RCT will evaluate whether routinely implementing training and monitoring CHW behavior and MCH outcomes with mobile phones, and providing data-informed supervision, will result in CHW becoming more effective. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, 15 months, and 24 months later. The primary outcome will be maternal HIV/TB testing, linkage to care, treatment adherence and retention in medical regimens, depression, and parenting; and her child's physical growth, cognitive functioning, and behavior adjustment.
- Conditions
- HIV, Partner Violence, Malnutrition, Alcohol Use/Abuse, Depression
- Being tested
- Accountable Condition, Control Condition
- Keywords
- Pregnancy, Home Healthcare Visits, Community Health Workers, Infants
- Medical subject headings
- Malnutrition, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accountable ConditionBehavioural
Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive ongoing monitoring and supervision. CHW will monitor mother's health and linkage to care; CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. CHW will also have a mobile phone to record information at each visit. CHW will log their home visits each day, rate the content and skills addressed on the mobile phone, weigh children, and report outcome achievements (e.g., receiving the child grant, immunizations, breastfeeding, and retention/ adherence to HIV care). The CHW in this arm will receive data-informed supervision. CHW will be monitored weekly with review of contact logs, recorded outcomes, and random site visits by supervising in-service training on a monthly basis. The Accountable Condition will last for two years (until the child is 24 months old).
Control ConditionBehavioural
Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive supervision and monitoring consistent with local government practices. CHW will monitor mother's health and linkage to care. CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. The Control Condition will last for two years (until the child is 24 months old).
| Study group | Role | What they receive |
|---|---|---|
| Accountable Condition- 8 clinics | Experimental | In the Accountable Condition, the intervention includes mothers who will receive home visits from government-funded CHW who will be trained once under Philani and receive ongoing monitoring and supervision. Receives: Behavioral: Accountable Condition |
| Control Condition- 8 clinics | Experimental | The Control Condition will include mothers who receive home visits from government-funded CHW who will be trained once under Philani and receive supervision and monitoring consistent with local government practices. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of significantly improved child and maternal outcomes
Out of 10 variables, the investigators total number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition. The variables are for mothers and children:
For Mothers:
- Adhere to medical regimens
- Breastfeed for six months (mixed ok)
- No alcohol after learning that the participant was pregnant
- Mental health, EPDS For Children:
- Growth in height (<-2SD)
- Growth in weight (<-2SD)
- Number of Hospitalizations
- WHO developmental scale measure in normal range
- In normal range of CBCL
- In normal range on the Bayley
Measured: 2 Years
Secondary outcomes (1)
Number of significantly improved child and maternal outcomes for HIV positive mothers
Out of 9 variables, the investigators total the number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition for HIV positive mothers. The variables are:
- ARV 6 weeks before birth
- NVP at birth
- Cipro for child
- TB testing
- AZT for child
- PCR testing at 6 weeks
- Get the results of PCR testing
- One feeding method for 6 months
- Breastfeed solely for 6 months.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Jun 2017
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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 University of California, Los AngelesThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Stellenbosch
- Responsible party
- Principal investigator, Mary Jane Rotheram-Borus, University of California, Los Angeles
- Investigators
- Mary Jane Rotheram-Borus, Principal investigator, Study Principal Investigator Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957799
- Sponsor's protocol ID
- R01MH111391
- Other IDs
- R01MH111391
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2016
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of this study we have a plan to de-identify the data and to make it available to other researchers.
Publications
Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.
PubMed 38682758Rotheram-Borus MJ, le Roux KW, Norwood P, Stansert Katzen L, Snyman A, le Roux I, Dippenaar E, Tomlinson M. The effect of supervision on community health workers' effectiveness with households in rural South Africa: A cluster randomized controlled trial. PLoS Med. 2023 Mar 2;20(3):e1004170. doi: 10.1371/journal.pmed.1004170. eCollection 2023 Mar.
PubMed 36862754Rotheram-Borus MJ, Le Roux K, Le Roux IM, Christodoulou J, Laurenzi C, Mbewu N, Tomlinson M. To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial. Trials. 2017 Aug 7;18(1):368. doi: 10.1186/s13063-017-2074-5.
PubMed 28784142
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
- ClinicalTrials.gov ID
- NCT02957799
- Acronym / sponsor ID
- R01MH111391
- Conditions
- HIV, Partner Violence, Malnutrition, Alcohol Use/Abuse, Depression
- Keywords
- Pregnancy, Home Healthcare Visits, Community Health Workers, Infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Stellenbosch
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Nov 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.
The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.
Detailed description
Each dollar invested in maternal, child health (MCH) yields a nine-fold benefit. Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes, including when delivered by CHW in low and middle income countries (LMIC). However, when home visiting programs are scaled, they are not effective. Africa has particular challenges with broad implementation of effective interventions often associated with the poorly trained and poorly monitored health personnel, in this case, CHW who are perinatal home visitors.
The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in a successful randomized controlled trial (RCT) conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood - to avoid stigma and to address multiple challenges concurrently. The visits significantly improved maternal and child outcomes over three years. Based on these results, the Philani Intervention Model served as one model for re-engineering primary health care for 65,000 CHW in South Africa. The Mthatha Provincial Government has agreed for the Philani Program to train, monitor, and supervise their already-hired CHW. This RCT will evaluate whether routinely implementing training and monitoring CHW behavior and MCH outcomes with mobile phones, and providing data-informed supervision, will result in CHW becoming more effective. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, 15 months, and 24 months later. The primary outcome will be maternal HIV/TB testing, linkage to care, treatment adherence and retention in medical regimens, depression, and parenting; and her child's physical growth, cognitive functioning, and behavior adjustment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accountable Condition- 8 clinics | Experimental | Behavioral: Accountable ConditionIn the Accountable Condition, the intervention includes mothers who will receive home visits from government-funded CHW who will be trained once under Philani and receive ongoing monitoring and supervision. |
| Control Condition- 8 clinics | Experimental | Behavioral: Control ConditionThe Control Condition will include mothers who receive home visits from government-funded CHW who will be trained once under Philani and receive supervision and monitoring consistent with local government practices. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Mothers living in the catchment area
- Mothers not identified as psychotic or delusional based on the interviewer's judgment
- Mothers able to provide informed consent
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Inability to converse with the interviewer or the CHW
- Death of the mother or infant.
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 |
|---|---|---|
| Accountable ConditionMothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive ongoing monitoring and supervision. CHW will monitor mother's health and linkage to care; CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. CHW will also have a mobile phone to record information at each visit. CHW will log their home visits each day, rate the content and skills addressed on the mobile phone, weigh children, and report outcome achievements (e.g., receiving the child grant, immunizations, breastfeeding, and retention/ adherence to HIV care). The CHW in this arm will receive data-informed supervision. CHW will be monitored weekly with review of contact logs, recorded outcomes, and random site visits by supervising in-service training on a monthly basis. The Accountable Condition will last for two years (until the child is 24 months old). | Behavioural | Accountable Condition- 8 clinics |
| Control ConditionMothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive supervision and monitoring consistent with local government practices. CHW will monitor mother's health and linkage to care. CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. The Control Condition will last for two years (until the child is 24 months old). | Behavioural | Control Condition- 8 clinics |
Primary outcome
Number of significantly improved child and maternal outcomes
Time frame: 2 Years
Out of 10 variables, the investigators total number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition. The variables are for mothers and children: For Mothers: 1. Adhere to medical regimens 2. Breastfeed for six months (mixed ok) 3. No alcohol after learning that the participant was pregnant 4. Mental health, EPDS For Children: 5. Growth in height (<-2SD) 6. Growth in weight (<-2SD) 7. Number of Hospitalizations 8. WHO developmental scale measure in normal range 9. In normal range of CBCL 10. In normal range on the Bayley
1 secondary outcome
Number of significantly improved child and maternal outcomes for HIV positive mothers
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 38682758Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.
- Derived from this study: PubMed 36862754Rotheram-Borus MJ, le Roux KW, Norwood P, Stansert Katzen L, Snyman A, le Roux I, Dippenaar E, Tomlinson M. The effect of supervision on community health workers' effectiveness with households in rural South Africa: A cluster randomized controlled trial. PLoS Med. 2023 Mar 2;20(3):e1004170. doi: 10.1371/journal.pmed.1004170. eCollection 2023 Mar.
- Derived from this study: PubMed 28784142Rotheram-Borus MJ, Le Roux K, Le Roux IM, Christodoulou J, Laurenzi C, Mbewu N, Tomlinson M. To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial. Trials. 2017 Aug 7;18(1):368. doi: 10.1186/s13063-017-2074-5.
- Individual participant dataSharing planned: Yes. At the conclusion of this study we have a plan to de-identify the data and to make it available to other researchers.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Mary Jane Rotheram-Borus principal investigator
Study Principal Investigator Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Accountable Condition in people with HIV and Partner Violence, run by University of California, Los Angeles at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. 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. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of significantly improved child and maternal outcomes (time frame: 2 Years). 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 NCT02957799, 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 14 Oct 2021.