HivPACARTNCT03200054
Postpartum Adherence Clubs for Antiretroviral Therapy
A study testing Adherence Clubs in people with Hiv, run by University of Cape Town at 1 site in South Africa.
Trial summary
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("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?
- Adherence Clubs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2016to Nov 2020
- 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
- Documented HIV infection with ART initiation during the preceding antenatal period
- Within 70 days post-delivery
- Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
- Willingness to be randomised and return for study measurement visits
- Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
- Able to provide informed consent for research
Who cannot join
- Intention to relocate out of Cape Town permanently during the study period
- 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/antiretrovirals (ARVs) and/or denial of HIV status
- Loss of pregnancy/neonate at the time of eligibility determination
- Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gugulethu Community Health Centre
Cape Town, Western Cape, 7750
About this study
Official title: Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
Read the detailed description
South Africa 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+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities. However, there are few well developed models of service delivery to support implementation. There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally. Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care. ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART. The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy. Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
- Conditions
- Hiv
- Being tested
- Adherence Clubs
- Keywords
- therapy, postnatal
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence ClubsOther
Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC). AC visits occur 2-4 monthly at a community hall near the CHC. At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART. Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse. A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit. Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based Care | No intervention | Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services. |
| Adherence Club Care | Experimental | Adherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses. Receives: Other: Adherence Clubs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Time to viral load >1000 copies per ml
Measured: 24 months
Secondary outcomes (16)
Maternal retention in care
Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
Measured: 24 months
Maternal death
Maternal deaths over the study period
Measured: 24 months
Maternal mental health
Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
Measured: 24 months
Maternal health care service use
Use of health facilities including hospitalization
Measured: 24 months
Infant death
Infant deaths over the study period
Measured: 24 months
Infant health care service use
Use of health facilities including hospitalization
Measured: 24 months
Infant HIV testing
Uptake of routine infant HIV testing
Measured: 24 months
Infant HIV infection
Mother-to-child transmission of HIV
Measured: 24 months
Infant feeding
Breastfeeding practices
Measured: 24 months
Cost and cost-effectiveness
Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
Measured: 24 months
Acceptability of each ART service
Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
Measured: 24 months
Viral suppression at other cutpoints (>400 copies/mL)
Time to VL >400 copies/mL
Measured: 24 months
Viral suppression at other cutpoints (>50 copies/mL)
Time to VL >50 copies/mL
Measured: 24 months
Virologic Failure
Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
Measured: 24 months
Combined retention/VL outcome
Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
Measured: 24 months
Viral suppression at each study visit
VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startJan 2016
- Primary completionJan 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Professor Landon Myer, University of Cape Town
- Investigators
- Landon Myer, MBChB PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200054
- Sponsor's protocol ID
- 195/2015
- Acronym
- PACART
- Status last verified
- May 2022
- First submitted
- 21 Mar 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
PubMed 18670232Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
PubMed 22951634Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
PubMed 23351797Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
PubMed 23440538Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
PubMed 23418518Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03200054
- Acronym / sponsor ID
- PACART / 195/2015
- Conditions
- Hiv
- Keywords
- therapy, postnatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 27 Jun 2017 (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.
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
Detailed description
South Africa 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+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities. However, there are few well developed models of service delivery to support implementation. There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally. Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care. ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART. The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy. Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based Care | No intervention | –Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services. |
| Adherence Club Care | Experimental | Other: Adherence ClubsAdherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV infection with ART initiation during the preceding antenatal period
- Within 70 days post-delivery
- Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
- Willingness to be randomised and return for study measurement visits
- Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
Key exclusion criteria (4 listed)
- Intention to relocate out of Cape Town permanently during the study period
- 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/antiretrovirals (ARVs) and/or denial of HIV status
- Loss of pregnancy/neonate at the time of eligibility determination
- Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
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 |
|---|---|---|
| Adherence ClubsWomen will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC). AC visits occur 2-4 monthly at a community hall near the CHC. At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART. Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse. A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit. Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse. | Other | Adherence Club Care |
Primary outcome
Viral suppression
Time frame: 24 months
Time to viral load >1000 copies per ml
16 secondary outcomes
Maternal retention in care
Time frame: 24 months
Maternal death
Time frame: 24 months
Maternal mental health
Time frame: 24 months
Maternal health care service use
Time frame: 24 months
Infant death
Time frame: 24 months
Infant health care service use
Time frame: 24 months
Infant HIV testing
Time frame: 24 months
Infant HIV infection
Time frame: 24 months
Infant feeding
Time frame: 24 months
Cost and cost-effectiveness
Time frame: 24 months
Acceptability of each ART service
Time frame: 24 months
Viral suppression at other cutpoints (>400 copies/mL)
Time frame: 24 months
Viral suppression at other cutpoints (>50 copies/mL)
Time frame: 24 months
Virologic Failure
Time frame: 24 months
Combined retention/VL outcome
Time frame: 24 months
Viral suppression at each study visit
Time frame: 24 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 18 May 2022.
- Background: PubMed 18670232Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
- Background: PubMed 22951634Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
- Background: PubMed 23351797Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
- Background: PubMed 23440538Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
- Background: PubMed 23418518Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
- BackgroundProvincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Landon Myer, MBChB PhD 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 Adherence Clubs in people with Hiv, run by University of Cape Town 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 6 inclusion and 4 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 18 May 2022. 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?
Viral suppression (time frame: 24 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 NCT03200054, which also lists 6 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 18 May 2022.