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

NCT ID: NCT03213223

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 468 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-18
• Study Completion Date: 2018-07-30

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. 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.

Conditions

Prevention of Mother-to-child Transmission of HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NORHED

UNKNOWN

Sponsor Role: collaborator

University of Zimbabwe

OTHER

Sponsor Role: lead

Responsible Party

Augustine Ndaimani

(Lecturer, Faculty of Medicine, Principal Investigator, DPhil Student).

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Augustine Ndaimani, DPhil MD (Student)

Role: PRINCIPAL_INVESTIGATOR

University of Zimbabwe

Locations

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

Marondera, Mashonaland East Province, Zimbabwe

Countries

Zimbabwe

Other Identifiers

A2087

Identifier Type: -

Identifier Source: org_study_id