Retention of Women in the PMTCT (Prevention of Mother-to-child Transmission of HIV)

NCT03213223 | Completed

• 1 other identifier: A2087
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

EXECUTIVE SUMMARY RESEARCH QUESTION TO BE ADDRESSED BY THIS PROPOSAL What are the factors associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT (elimination of mother-to-child transmission of HIV) sites with high retention-in-care compared to eMTCT sites with low retention in care? Hypotheses Null hypothesis H0: The attributable rate of low retention-in-care of women in the eMTCT program at eMTCT sites equals zero. Alternative hypothesis HA: The attributable risk of low retention-in-care of women in the eMTCT program at eMTCT sites is not equal to zero. RATIONALE FOR RESEARCH There is poor retention of women along the PMTCT (prevention of mother to child transmission of HIV) cascade. Retention in eMTCT refers to documented regular participation of the pregnant woman, confirmed HIV positive, together with her child or children not yet confirmed as HIV-positive, in all prescribed activities aimed at preventing transmission of HIV from her to the child, and scheduled or unscheduled HIV-care related visits, measured during or at the end of care. It results in uninterrupted supply of ART (antiretroviral therapy). Retention in PMTCT ranges between 10.6% and 76.5% in other countries. In Zimbabwe it was found to drop from 83% at second pick up of antiretroviral drugs to 45% at fourth pick up of antiretroviral drugs. Poor retention in PMTCT leads to poor health outcomes in the mother and the baby. These include increased viral load, reduced CD4 count, reduced adherence to ART, emergency of drug resistant HIV strains, reduced quality of life, increased frequency of opportunistic infections, increased all-cause hospitalizations and death of women and children. HIV infection contributes to between 6 and 20% of maternal deaths. On the other hand, about 14% of all new infections are due to MTCT (mother to child transmission of HIV). Retention in care is better at some clinics and hospitals. The purpose of the study will be to determine the factors associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT sites. The following objectives will be addressed in the study:

1. 1.To assess the PMTCT Option B Plus program at selected eMTCT sites.
2. 2.To determine the prevalence of retention among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
3. 3.To determine the incidence of attrition among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
4. 4.To identify factors associated with variability in levels of retention-in-care of women in the eMTCT Option B+ program at selected eMTCT sites.
5. 5.To explore the barriers and facilitators of retention among women enrolled in the eMTCT Option B+ program.

Conditions

Prevention of Mother-to-child Transmission of HIV

Keywords

retention; attrition; PMTCT; elimination of mother to child transmission of HIV

Outcome Measures

Primary Outcomes (2)

• Retention in care based on record review and follow up data

  Missed visit count (number of missed visits), Dichotomous missed visit (more than one missed visit), Visit adherence (number of kept visits divided by the total number of scheduled visits), Four month constancy (the number of four month intervals in which the individual came for PMTCT at least once), 6-month gap (no visit in a 6-month period), HRSA HAB (Health Resources and Services administration HIV-AIDS Bureau) \[2 kept visits separated by at least 90 days in a year)

  One follow-up per 3-month period, up to 12 months

• Attrition from PMTCT (determined through survival analysis based on Cox proportional hazards regression)

  Death or loss to follow - up from PMTCT

  One follow-up per 3-month period, up to 12 months

Secondary Outcomes (1)

• Barriers and enablers of retention (focus group discussions)

  One focus group per week, up to 4 weeks, (total of four focus group discussions)

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Pregnant or breastfeeding women in the PMTCT program
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The target population in the study will consist of women who are enrolled in eMTCT Option B+ program. The accessible population will be women enrolled and coming for PMTCT services at eMTCT sites in Mashonaland East Province.

You may qualify if:

• women 15-49 years. On PMTCT tes and treat strategy or Option B+

You may not qualify if:

• mentally unstable women or not enrolled at the study sites for PMTCT. Women enrolled in Option B Censoring - after a miscarriage, still birth, on leaving the PMTCT program and at the end of the study

Sponsors & Collaborators

• University of Zimbabwe: lead
• NORHED: collaborator

Study Sites (1)

Mashonaland East Province (Mutoko Hospital, Murewa Hospital, Kunaka Hospital, Nharira Hospital, Chichu Clinic, Epworth Polyclinic)

Marondera, Mashonaland East Province, Zimbabwe

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Augustine Ndaimani, DPhil MD (Student)

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (Lecturer, Faculty of Medicine, Principal Investigator, DPhil Student).

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: November 18, 2016
• Primary Completion: November 30, 2017
• Study Completion: July 30, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)