Promoting Uptake and Retention of Option B+ in Malawi (PURE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Lighthouse Trust
Sponsor:
Collaborators:
World Health Organization
AIDS Fonds
Mothers2Mothers
University of Malawi College of Medicine
MSH (Management Sciences for Health)
Dignitas International
University of North Carolina, Chapel Hill
University of Malawi
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Sam Phiri, PhD, MSc, DCM, Lighthouse Trust
ClinicalTrials.gov Identifier:
NCT02005835
First received: December 4, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.


Condition Intervention
HIV
Other: Community based peer support
Other: Facility-based Peer Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi

Resource links provided by NLM:


Further study details as provided by Lighthouse Trust:

Primary Outcome Measures:
  • Retention in Care [ Time Frame: 12 months post ART initiation ] [ Designated as safety issue: No ]
    The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.


Secondary Outcome Measures:
  • Retention at 24 months [ Time Frame: 24 months post ART initiation ] [ Designated as safety issue: No ]
    The proportion of Women alive and retained on ART at 24 months post ART initiation

  • Child HIV status [ Time Frame: 6 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
    Children tested at 6 weeks, 12 months, and 24 months

  • HIV free survival [ Time Frame: 6 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
    HIV-free infant survival at 6-weeks, 12 months and 24 months

  • Family retention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Partner/family involvement, including: a) husband/children tested for HIV; b. eligible husbands/children who start ART; c. husband/children engaged in care at 12 months

  • Maternal Viral Load [ Time Frame: 6 months and 2 years post ART initiation ] [ Designated as safety issue: Yes ]
    Proportion of women with HIVRNA <1000 copies at 6 months and 2 years post initiation

  • Maternal resistance [ Time Frame: 6 months, 2 years ] [ Designated as safety issue: Yes ]
    Of women failing ART, the proportion with HIV drug resistance

  • Infant HIV resistance [ Time Frame: 6 weeks, 12 months, 24 months ] [ Designated as safety issue: Yes ]
    Of HIV infected infants, the proportion with HIV drug resistance

  • Social outcomes [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]
    Social outcomes, including impact of task shifting on burden of care in facilities, quality of life for patients and their families, disclosure and shifts in boundaries of professional and lay care for lay health care workers as assessed by mixed methodology.


Other Outcome Measures:
  • Economics [ Time Frame: baseline, 12, 24 months ] [ Designated as safety issue: No ]
    Economic indicators including cost effectiveness ratios of support models, equity of access to PMTCT services by geographic area, socio-economic profiles of mothers and families accessing care to assess equity, and indicators for health system impacts such as time at work, overtime, number and types of cases treated, motivation and satisfaction by health workers as assessed by mixed methodology.


Estimated Enrollment: 1050
Study Start Date: November 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Facility-based Peer Support

Facility-based Peer Support to provide the following at the clinic

  • Routine standard clinical care based on the MoH guidelines
  • Mentor mothers provide education and psychosocial support at facility
  • Weekly support groups provided in clinic
  • Phone call, SMS, or home visit for each missed appointment
Other: Facility-based Peer Support

Facility-based Peer Support to provide the following at the clinic

Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment

Community-based Peer Support

Community-based Support from Peer Mothers (Expert mothers):

  • Routine standard clinical care based on the MoH guidelines
  • Mentor mothers provide education and psychosocial support in community prior to each visit
  • Monthly support groups in community
  • Home visits for each missed appointment
Other: Community based peer support

Community-based Support from Peer Mothers (Expert mothers):

Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment

No Intervention: Standard of Care
The Standard of care as outlined in the Malawi HIV integrated Care Guidelines

Detailed Description:

The Malawi Ministry of Health (MoH) has embarked on a novel and ambitious programme to prevent mother to child transmission of HIV (PMTCT) known as "Option B Plus". This programme takes a public health approach to promote maternal health and eliminate paediatric HIV infections through a "test and treat" model, offering all HIV-infected pregnant and breastfeeding women lifelong ART regardless of CD4 count or clinical stage. The overall goal is to improve ART uptake and retention, and thus outcomes, of HIV-infected pregnant women and their infants in the continuum of ART services.

Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).

The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.

We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected women Presenting for Antenatal Care, Labor&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005835

Contacts
Contact: Clement Trapence, MSc. 265 1 758897 c_Trapence@lighthouse.org.mw
Contact: Hannock Tweya, M.P.H. 265 1 758897 h_Tweya@lighthouse.org.mw

Locations
Malawi
Ministry of Health Facilities Recruiting
Lilongwe, Malawi
Principal Investigator: Sam Phiri, Ph.D., MSc         
Sub-Investigator: Hannock Tweya, MSc.,BSc.         
Sub-Investigator: Erik Schouten, M.D.         
Sub-Investigator: Michael Eliya, MPH         
Sub-Investigator: Frank Chibwandira, MBBS, MPH         
Sub-Investigator: Fabian Cataldo, PhD         
Sub-Investigator: Monique van Lettow, MPH, PhD         
Sub-Investigator: Megan Landes, MD, MSc         
Sub-Investigator: Mina Hosseinipour, MD, MPH         
Sub-Investigator: Nora Rosenberg, PhD, MSc.         
Sub-Investigator: Innocent Mofolo, MA         
Sub-Investigator: Levison Chiwaula, BSc, MA, PhD         
Sub-Investigator: Atupele Kapito-Tembo, MBBS, PhD         
Sub-Investigator: Veena Sampathkumar         
Sponsors and Collaborators
Lighthouse Trust
World Health Organization
AIDS Fonds
Mothers2Mothers
University of Malawi College of Medicine
MSH (Management Sciences for Health)
Dignitas International
University of North Carolina, Chapel Hill
University of Malawi
Ministry of Health and Population, Malawi
Investigators
Principal Investigator: Sam Phiri, PhD, MSc. Lighthouse Trust
  More Information

No publications provided

Responsible Party: Sam Phiri, PhD, MSc, DCM, Executive Director, Lighthouse Trust
ClinicalTrials.gov Identifier: NCT02005835     History of Changes
Other Study ID Numbers: PUREMalawi
Study First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: Malawi: National Health Sciences Research Committee
United Nations: World Health Organization

Keywords provided by Lighthouse Trust:
HIV
Option B+
Prevention of Mother to Child Transmission

ClinicalTrials.gov processed this record on September 16, 2014