HIVPACERNCT02417675
Postpartum Adherence Clubs to Enhance Support: the PACER Study
A study testing Community-based Adherence Clubs in people with HIV, run by Columbia University at 1 site in South Africa.
Trial summary
The Western Cape province of South Africa (SA) is changing the way it treats pregnant women with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are, will receive antiretroviral treatment (ART) for life ("Option B+"). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Community-based Adherence Clubs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2015to 31 Oct 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Documented HIV-infection according to two finger-prick rapid tests using different test types (per routine protocol in this setting) or documentation of HIV status for those women self reporting HIV diagnosis.
- Initiated ART during the antenatal period (during most recent pregnancy)
- Within one month postpartum
- Currently breastfeeding within one month postpartum
- Willingness to return for postnatal study visits
Show all 12Show fewer
- Able to provide informed consent for research
- Eligible to receive care at local Adherence Club, based on following local eligibility criteria:
- Virally suppressed (HIV RNA <1000 copies/mL) per most recent viral load test (conducted during pregnancy)
- Clinically stable (no active co-morbidity including opportunistic infections)
- Current resident of a catchment area appropriate for Adherence Club referral
- Infants of women enrolled in the study.
Who cannot join
- Receipt of any ART services outside the Gugulethu MOU ART service in the postpartum period
- Intention to relocate out of Cape Town permanently during the following one year
- Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study, including:
- Refusal to take ART/ARVs
- Denial of HIV status
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gugulethu Community Health Centre
Cape Town, Western Cape
About this study
The Western Cape province of South Africa (SA) is changing the way it treats pregnant women with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are, will receive antiretroviral treatment (ART) for life ("Option B+"). However, there are few well-developed models of service delivery to support this change to "Option B+" in the Western Cape and many parts of the continent.
The parent study -- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs have been used to free up space at ART clinics by moving stable HIV+ patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women after delivery. PACER seeks to address this gap.
Read the detailed description
The Western Cape province of South Africa (SA) is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). However there are few well-developed models of service delivery to support implementation of "Option B+" in the Western Cape and many parts of the continent. In particular, while systems for initiation and follow-up of pregnant women on ART are based within well-established antenatal care clinics (ANC), there are major concerns regarding delivery of ART to HIV-infected women during the postpartum period. Multiple studies indicate high levels of non-retention in care, and/or inadequate ART adherence, during the postpartum period, presenting a threat to HIV-infected women and their infants.4-8 In turn, there is an urgent need for evidence-based approaches to support the growing number of HIV-infected mothers on ART.
In this context, the parent study-- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- provides a rigorous implementation science framework for understanding optimal approaches for managing HIV-infected women and their HIV-exposed infants in the first year after delivery under "Option B+". While MCH-ART focuses on clinic-based models of care, there is also growing attention to the role of community health workers (CHWs) in supporting patients on ART, including community-based distribution and adherence support away from health facilities.To complement MCH-ART, the PACER study aims to investigate community-based Adherence Clubs as an effective model for engaging and retaining breastfeeding women beyond pregnancy to maximize maternal and infant health. In Cape Town, specifically, Adherence Clubs have been developed in which ART services are located away from clinics and are led by CHWs with support from ART clinic nurses. These clubs have been implemented to help decongest ART clinics by shifting stable patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women in the postpartum period. PACER seeks to address this gap by randomizing women in the parent study, MCH-ART, to either the AC system or to the nearest adult ART clinic. Infants in both arms will receive the same services, following the local standard of care.
- Conditions
- HIV
- Being tested
- Community-based Adherence Clubs, Standard of Care for Mothers, Standard of Care for Infants
- Keywords
- Option B+, Adherence Club, Postpartum, Breastfeeding, Mother-to-child transmission
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based Adherence ClubsOther
Also called AC
Women in the AC arm are prescribed 2 months of their current ART medication (compared to 1 month in the SOC) and will be advised to go to the AC office immediately, where they will be scheduled for their first session. Women will attend AC meetings every two months. At these meetings, women will receive a 2 month supply of medication, health education and peer-support. A trained Community Health Worker (CHW) will also collect blood samples, weight, and current signs/symptoms from women.
Each participant has 5 working days after their AC session to come and collect her medication. Those who have defaulted will be followed up by the CHW via phone calls and, possibly, home visits. If reached, women will be told to return immediately to the main ART facility for receipt of ART care.
Standard of Care for MothersOther
Also called SOC
Women will be referred immediately from the maternity ART clinic to their nearest adult ART clinic at their first postpartum clinic visit. At referral, they receive an initial 1-month supply of their current ART medication. At the first appointment after transfer into the general ART service, patients undergo clinical history and examination by a doctor or clinical nurse practitioner. Laboratory investigations are ordered according to standard protocols or based on clinician discretion. For the 1st 4 months in the new service, stable patients are dispensed 1 month of ART; subsequent visits are 2-monthly for medication refill, with clinician review 6-monthly; patients with particular clinical or psychosocial concerns may be reviewed more regularly, or referred to higher levels of care.
Standard of Care for InfantsOther
All infants will receive care at their nearest primary care clinic. Following national protocols, all HIV-infected mothers are issued a 6-week supply of nevirapine syrup after delivery and counselled on daily nevirapine prophylaxis. Infant follow-up takes place within 1 week postpartum with the mother (at the MOU) and then at 6 weeks postpartum (at the nearest primary care clinic) when HIV PCR testing of the infant is carried out. Following national protocols, infants who are breastfed beyond 6 weeks receive HIV PCR testing 2-4 weeks after the cessation of breastfeeding, again conducted at the nearest City of Cape Town primary care clinic.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Women who choose the SOC will receive postpartum antiretroviral therapy (ART) services at their nearest primary care clinic, following the Standard of Care for Mothers. Details are provided in the intervention description.
Infants receive the same care in each arm, according to the Standard of Care for Infants. Receives: Other: Standard of Care for Mothers; Other: Standard of Care for Infants |
| Intervention (AC) | Experimental | Women who choose the Community-based Adherence Clubs (AC) will receive postpartum antiretroviral therapy (ART) services at an AC, rather than at their nearest primary care clinic as in the SOC arm. Details are provided in the intervention section.
Infants receive the same care in each arm, according to the Standard of Care for Infants. Receives: Other: Community-based Adherence Clubs; Other: Standard of Care for Infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal retention
Proportion of mothers retained in HIV care and adhering to ART at 12 months postpartum
Measured: 12 months
Secondary outcomes (5)
Maternal Loss to Follow-up
Proportion of women who are lost to follow-up on ART at 12 months postpartum.
Measured: 12 months
Maternal Viral Suppression
Proportion of women with viral suppression at the end of the breastfeeding period.
Measured: 12 months
Infant HIV diagnosis
Proportion of infants receiving proper HIV diagnosis at 12 months postpartum
Measured: 12 months
Infant vaccination
Proportion of infants receiving proper vaccinations at 12 months postpartum
Measured: 12 months
Mother-to-child transmission
Rate of HIV transmission from mother-to-child
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 posted16 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
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.
- More trials run by Columbia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine J Abrams, MD, Principal investigator, ICAP at Columbia UniversityLandon Myer, MD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417675
- Sponsor's protocol ID
- AAAO5601
- Other IDs
- 3R01HD074558-03S1
- Acronym
- PACER
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zerbe A, Brittain K, Phillips TK, Iyun VO, Allerton J, Nofemela A, Kalombo CD, Myer L, Abrams EJ. Community-based adherence clubs for postpartum women on antiretroviral therapy (ART) in Cape Town, South Africa: a pilot study. BMC Health Serv Res. 2020 Jul 8;20(1):621. doi: 10.1186/s12913-020-05470-5.
PubMed 32641032Trafford Z, Gomba Y, Colvin CJ, Iyun VO, Phillips TK, Brittain K, Myer L, Abrams EJ, Zerbe A. Experiences of HIV-positive postpartum women and health workers involved with community-based antiretroviral therapy adherence clubs in Cape Town, South Africa. BMC Public Health. 2018 Jul 31;18(1):935. doi: 10.1186/s12889-018-5836-4.
PubMed 30064405
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Adherence Clubs to Enhance Support: the PACER Study
- ClinicalTrials.gov ID
- NCT02417675
- Acronym / sponsor ID
- PACER / AAAO5601
- Conditions
- HIV
- Keywords
- Option B+, Adherence Club, Postpartum, Breastfeeding, Mother-to-child transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2015
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 16 Apr 2015 (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 Western Cape province of South Africa (SA) is changing the way it treats pregnant women with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are, will receive antiretroviral treatment (ART) for life ("Option B+"). However, there are few well-developed models of service delivery to support this change to "Option B+" in the Western Cape and many parts of the continent.
The parent study -- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs have been used to free up space at ART clinics by moving stable HIV+ patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women after delivery. PACER seeks to address this gap.
Detailed description
The Western Cape province of South Africa (SA) is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). However there are few well-developed models of service delivery to support implementation of "Option B+" in the Western Cape and many parts of the continent. In particular, while systems for initiation and follow-up of pregnant women on ART are based within well-established antenatal care clinics (ANC), there are major concerns regarding delivery of ART to HIV-infected women during the postpartum period. Multiple studies indicate high levels of non-retention in care, and/or inadequate ART adherence, during the postpartum period, presenting a threat to HIV-infected women and their infants.4-8 In turn, there is an urgent need for evidence-based approaches to support the growing number of HIV-infected mothers on ART.
In this context, the parent study-- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- provides a rigorous implementation science framework for understanding optimal approaches for managing HIV-infected women and their HIV-exposed infants in the first year after delivery under "Option B+". While MCH-ART focuses on clinic-based models of care, there is also growing attention to the role of community health workers (CHWs) in supporting patients on ART, including community-based distribution and adherence support away from health facilities.To complement MCH-ART, the PACER study aims to investigate community-based Adherence Clubs as an effective model for engaging and retaining breastfeeding women beyond pregnancy to maximize maternal and infant health. In Cape Town, specifically, Adherence Clubs have been developed in which ART services are located away from clinics and are led by CHWs with support from ART clinic nurses. These clubs have been implemented to help decongest ART clinics by shifting stable patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women in the postpartum period. PACER seeks to address this gap by randomizing women in the parent study, MCH-ART, to either the AC system or to the nearest adult ART clinic. Infants in both arms will receive the same services, following the local standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Other: Standard of Care for Mothers, Other: Standard of Care for InfantsWomen who choose the SOC will receive postpartum antiretroviral therapy (ART) services at their nearest primary care clinic, following the Standard of Care for Mothers. Details are provided in the intervention description. Infants receive the same care in each arm, according to the Standard of Care for Infants. |
| Intervention (AC) | Experimental | Other: Community-based Adherence Clubs, Other: Standard of Care for InfantsWomen who choose the Community-based Adherence Clubs (AC) will receive postpartum antiretroviral therapy (ART) services at an AC, rather than at their nearest primary care clinic as in the SOC arm. Details are provided in the intervention section. Infants receive the same care in each arm, according to the Standard of Care for Infants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older
- Documented HIV-infection according to two finger-prick rapid tests using different test types (per routine protocol in this setting) or documentation of HIV status for those women self reporting HIV diagnosis.
- Initiated ART during the antenatal period (during most recent pregnancy)
- Within one month postpartum
- Currently breastfeeding within one month postpartum
Key exclusion criteria (5 listed)
- Receipt of any ART services outside the Gugulethu MOU ART service in the postpartum period
- Intention to relocate out of Cape Town permanently during the following one year
- Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study, including:
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-based Adherence ClubsAlso: ACWomen in the AC arm are prescribed 2 months of their current ART medication (compared to 1 month in the SOC) and will be advised to go to the AC office immediately, where they will be scheduled for their first session. Women will attend AC meetings every two months. At these meetings, women will receive a 2 month supply of medication, health education and peer-support. A trained Community Health Worker (CHW) will also collect blood samples, weight, and current signs/symptoms from women. Each participant has 5 working days after their AC session to come and collect her medication. Those who have defaulted will be followed up by the CHW via phone calls and, possibly, home visits. If reached, women will be told to return immediately to the main ART facility for receipt of ART care. | Other | Intervention (AC) |
| Standard of Care for MothersAlso: SOCWomen will be referred immediately from the maternity ART clinic to their nearest adult ART clinic at their first postpartum clinic visit. At referral, they receive an initial 1-month supply of their current ART medication. At the first appointment after transfer into the general ART service, patients undergo clinical history and examination by a doctor or clinical nurse practitioner. Laboratory investigations are ordered according to standard protocols or based on clinician discretion. For the 1st 4 months in the new service, stable patients are dispensed 1 month of ART; subsequent visits are 2-monthly for medication refill, with clinician review 6-monthly; patients with particular clinical or psychosocial concerns may be reviewed more regularly, or referred to higher levels of care. | Other | Standard of Care (SOC) |
| Standard of Care for InfantsAll infants will receive care at their nearest primary care clinic. Following national protocols, all HIV-infected mothers are issued a 6-week supply of nevirapine syrup after delivery and counselled on daily nevirapine prophylaxis. Infant follow-up takes place within 1 week postpartum with the mother (at the MOU) and then at 6 weeks postpartum (at the nearest primary care clinic) when HIV PCR testing of the infant is carried out. Following national protocols, infants who are breastfed beyond 6 weeks receive HIV PCR testing 2-4 weeks after the cessation of breastfeeding, again conducted at the nearest City of Cape Town primary care clinic. | Other | Intervention (AC), Standard of Care (SOC) |
Primary outcome
Maternal retention
Time frame: 12 months
Proportion of mothers retained in HIV care and adhering to ART at 12 months postpartum
5 secondary outcomes
Maternal Loss to Follow-up
Time frame: 12 months
Maternal Viral Suppression
Time frame: 12 months
Infant HIV diagnosis
Time frame: 12 months
Infant vaccination
Time frame: 12 months
Mother-to-child transmission
Time frame: 12 months
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 13 Feb 2018.
- Derived from this study: PubMed 32641032Zerbe A, Brittain K, Phillips TK, Iyun VO, Allerton J, Nofemela A, Kalombo CD, Myer L, Abrams EJ. Community-based adherence clubs for postpartum women on antiretroviral therapy (ART) in Cape Town, South Africa: a pilot study. BMC Health Serv Res. 2020 Jul 8;20(1):621. doi: 10.1186/s12913-020-05470-5.
- Derived from this study: PubMed 30064405Trafford Z, Gomba Y, Colvin CJ, Iyun VO, Phillips TK, Brittain K, Myer L, Abrams EJ, Zerbe A. Experiences of HIV-positive postpartum women and health workers involved with community-based antiretroviral therapy adherence clubs in Cape Town, South Africa. BMC Public Health. 2018 Jul 31;18(1):935. doi: 10.1186/s12889-018-5836-4.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Elaine J Abrams, MD principal investigator
ICAP at Columbia University
Landon Myer, MD principal investigator
University of Cape Town
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-based Adherence Clubs in people with HIV, run by Columbia University at 1 site 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 12 inclusion and 5 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 13 Feb 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 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.
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?
Maternal retention (time frame: 12 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 NCT02417675, 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 13 Feb 2018.