NCT03200054

Brief 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+"). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

March 21, 2017

Last Update Submit

May 17, 2022

Conditions

Hiv

Keywords

therapypostnatal

Outcome Measures

Primary Outcomes (1)

  • Viral suppression

    Time to viral load \>1000 copies per ml

    24 months

Secondary Outcomes (16)

  • Maternal retention in care

    24 months

  • Maternal death

    24 months

  • Maternal mental health

    24 months

  • Maternal health care service use

    24 months

  • Infant death

    24 months

  • +11 more secondary outcomes

Study Arms (2)

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.

Other: Adherence Clubs

Interventions

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.

Adherence Club Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, 7750, South Africa

Location

Related Publications (6)

  • 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.

    PMID: 18670232BACKGROUND

  • Nachega 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.

    PMID: 22951634BACKGROUND

  • Coutsoudis 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.

    PMID: 23351797BACKGROUND

  • Chi 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.

    PMID: 23440538BACKGROUND

  • Luque-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.

    PMID: 23418518BACKGROUND

  • Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.

    BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Landon Myer, MBChB PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head: Department of Public Health and Family Medicine

Study Record Dates

First Submitted

March 21, 2017

First Posted

June 27, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

November 1, 2020

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)