Prevention of Mother-to-child Transmission of HIV Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01774136 -
Effectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health Workers
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N/A |