Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2017 by Augustine Ndaimani, University of Zimbabwe

Sponsor
University of Zimbabwe

Collaborator
NORHED

Information provided by (Responsible Party)
Augustine Ndaimani, University of Zimbabwe

ClinicalTrials.gov Identifier
NCT03213223

First received: June 30, 2017
Last updated: October 24, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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. To assess the PMTCT Option B Plus program at selected eMTCT sites.
  2. To determine the prevalence of retention among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
  3. To determine the incidence of attrition among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
  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. To explore the barriers and facilitators of retention among women enrolled in the eMTCT
Option B+ program.

METHODS The study is being done through a nested, embedded, mixed methods study with priority given to a prospective cohort methodology. The supplementary design is a simple descriptive qualitative design carried out through focus group discussions. A mixed methods design caters for the weaknesses in either a qualitative or a quantitative design. Hence, it is ideal in study of complex human issues such as retention in the PMTCT Option B Plus program.

In the study, 462 pregnant women enrolled for PMTCT Option B Plus will be followed up for 12 months in an open cohort. The sample size was calculated using Stata software based on a power of 0.8, a margin of error of 0.05, a design effect of 1.1 and a retention rate of 0.45. Six randomly selected eMTCT sites in Mashonaland East Province were chosen for the study. Retention rate at the sites since 2013 will be calculated. Three sites with lower retention will be considered as the exposure sites. The other 3 sites will be the unexposed sites. Option B Plus, a recently introduced and recommended PMTCT option, was meant to benefit pregnant women, in addition to their children and sexual partners. Hence, the involvement of women as participants. Four focus group discussions will also be done, with nursing mothers to ascertain the barriers and facilitators of retention in PMTCT Option B plus. Included in the study will be HIV positive pregnant and nursing women coming for PMTCT Option B Plus. Women who can communicate in English or Shona and are without psychiatric conditions will also be included. Emancipated minors, below 18 years of age will also be included. Excluded from the study will be women enrolled in PMTCT Options A or B, women with psychiatric conditions or those who are too ill to participate. The study was approved by The Medical Research Council of Zimbabwe. Signed voluntary consent is sought from participants. Data is being collected through questionnaires and audio-taped focus group discussions. Follow-up data will also be extracted from eMTCT registers at respective eMTCT sites. Data is kept in locked cabinets only accessible to the principal investigator and the supervisors.

Condition
Prevention of Mother-to-child Transmission of HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retention-in-care of Women in the Elimination of Mother-to-child Transmission of HIV (eMTCT) Option B Plus Program in Mashonaland East, Zimbabwe: a Mixed Method Study

Further study details as provided by Augustine Ndaimani, University of Zimbabwe:

Primary Outcome Measures

  • Retention in care based on record review and follow up data [ Time Frame: One follow-up per 3-month period, up to 12 months ]
    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)
  • Attrition from PMTCT (determined through survival analysis based on Cox proportional hazards regression) [ Time Frame: One follow-up per 3-month period, up to 12 months ]
    Death or loss to follow - up from PMTCT
Secondary Outcome Measures:
  • Barriers and enablers of retention (focus group discussions) [ Time Frame: One focus group per week, up to 4 weeks, (total of four focus group discussions) ]
    Perceived barriers and facilitators of retention. Focus group discussions analysed through latent content analysis)

Estimated Enrollment: 462
Study Start Date: November 18, 2016
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 15 Years to 49 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  
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.

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
  • 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

contacts and locations

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: NCT03213223

Contacts

Contact:   Augustine Ndaimani, DPhil Student +263-778030082 ndaimania@gmail.com
Contact:   Inam Chitsike, Professor chitsikei@gmail.com

Locations

Zimbabwe
Mashonaland East Province (Mutoko Hospital, Murewa Hospital, Kunaka Hospital, Nharira Hospital, Chichu Clinic, Epworth Polyclinic) Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: Milca Chitongo
Contact:    +263-772864062

Sponsors and Collaborators

University of Zimbabwe
NORHED

Investigators

Principal Investigator: Augustine Ndaimani, DPhil MD (Student) University of Zimbabwe
More Information

More Information


Responsible Party: Augustine Ndaimani, (Lecturer, Faculty of Medicine, Principal Investigator, DPhil Student)., University of Zimbabwe  
ClinicalTrials.gov Identifier: NCT03213223   History of Changes  
Other Study ID Numbers: A2087  
Study First Received: June 30, 2017  
Last Updated: October 24, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Augustine Ndaimani, University of Zimbabwe:

retention
attrition
PMTCT
elimination of mother to child transmission of HIV

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.