Prevention of Mother-to-child Transmission of HIVNCT03213223
Retention of Women in the PMTCT (Prevention of Mother-to-child Transmission of HIV)
An observational study of Prevention of Mother-to-child Transmission of HIV, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Mother-to-child Transmission of HIV
- How many people
- 468 participants
- Where
- 1 siteZimbabwe
- Study dates
- 18 Nov 2016to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- women 15-49 years. On PMTCT tes and treat strategy or Option B+
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
Mashonaland East Province (Mutoko Hospital, Murewa Hospital, Kunaka Hospital, Nharira Hospital, Chichu Clinic, Epworth Polyclinic)
Marondera, Mashonaland East Province
About this study
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.
Read more
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:
- To assess the PMTCT Option B Plus program at selected eMTCT sites.
- To determine the prevalence of retention among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
- To determine the incidence of attrition among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
- To identify factors associated with variability in levels of retention-in-care of women in the eMTCT Option B+ program at selected eMTCT sites.
- 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.
- Keywords
- retention, attrition, PMTCT, elimination of mother to child transmission of HIV
- Medical subject headings
- Tooth Wear
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: One follow-up per 3-month period, up to 12 months
Secondary outcomes (1)
Barriers and enablers of retention (focus group discussions)
Perceived barriers and facilitators of retention. Focus group discussions analysed through latent content analysis)
Measured: One focus group per week, up to 4 weeks, (total of four focus group discussions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start18 Nov 2016
- Primary completion30 Nov 2017
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Mother-to-child Transmission of HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- NORHED
- Responsible party
- Principal investigator, Augustine Ndaimani, University of Zimbabwe
- Investigators
- Augustine Ndaimani, DPhil MD (Student), Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213223
- Sponsor's protocol ID
- A2087
- Status last verified
- Oct 2018
- First submitted
- 30 Jun 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03213223
- Acronym / sponsor ID
- A2087
- Keywords
- retention, attrition, PMTCT, elimination of mother to child transmission of HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- NORHED
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the PMTCT Option B Plus program at selected eMTCT sites.
- To determine the prevalence of retention among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
- To determine the incidence of attrition among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
- To identify factors associated with variability in levels of retention-in-care of women in the eMTCT Option B+ program at selected eMTCT sites.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- women 15-49 years. On PMTCT tes and treat strategy or Option B+
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Prevention of Mother-to-child Transmission of HIV
Recruiting
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
Human Immunodeficiency Virus, Mental Disorder
Recruiting
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
HIV Prevention
Recruiting
Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
Hiv, Transmission Vertical
RecruitingPhase 4
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Pre-exposure Prophylaxis, HIV Prevention
Recruiting
Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augustine Ndaimani, DPhil MD (Student) principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Mother-to-child Transmission of HIV, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in care based on record review and follow up data (time frame: One follow-up per 3-month period, up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.