Promoting Uptake and Retention of Option B+ in Malawi

HIV Clinical Trial

— PURE  

Official title:

Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02005835
• Other study ID #: PUREMalawi
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 4, 2013
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: December 2013
• Source: Lighthouse Trust
• Contact: Clement Trapence, MSc.
• Phone: 265 1 758897
• Email: c_Trapence[@]lighthouse.org.mw
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research CommitteeUnited Nations: World Health Organization
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: August 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

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
• 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

Locations

Country	Name	City	State
Malawi	Ministry of Health Facilities	Lilongwe

Sponsors (10)

Lead Sponsor	Collaborator
Lighthouse Trust	AIDS Fonds, Dignitas International, Ministry of Health and Population, Malawi, Mothers2Mothers, MSH (Management Sciences for Health), University of Malawi, University of Malawi College of Medicine, University of North Carolina, Chapel Hill, World Health Organization

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economics	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.	baseline, 12, 24 months	No
Primary	Retention in Care	The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.	12 months post ART initiation	No
Secondary	Retention at 24 months	The proportion of Women alive and retained on ART at 24 months post ART initiation	24 months post ART initiation	No
Secondary	Child HIV status	Children tested at 6 weeks, 12 months, and 24 months	6 weeks, 12 months, 24 months	No
Secondary	HIV free survival	HIV-free infant survival at 6-weeks, 12 months and 24 months	6 weeks, 12 months, 24 months	No
Secondary	Family retention	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	12 months	No
Secondary	Maternal Viral Load	Proportion of women with HIVRNA <1000 copies at 6 months and 2 years post initiation	6 months and 2 years post ART initiation	Yes
Secondary	Maternal resistance	Of women failing ART, the proportion with HIV drug resistance	6 months, 2 years	Yes
Secondary	Infant HIV resistance	Of HIV infected infants, the proportion with HIV drug resistance	6 weeks, 12 months, 24 months	Yes
Secondary	Social outcomes	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.	12, 24 months	No