HIVNCT03698981
Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women
A study testing Mothers Moving towards Empowerment (MME) in people with HIV, run by New York University at 1 site in Botswana.
Trial summary
The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will use empirically tested stigma interventions that have shown efficacy for serious mental illness and to adapt these to HIV. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- Mothers Moving towards Empowerment (MME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBotswana
- Study dates
- 15 Mar 2019to 14 Jan 2021
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primiparous women
- aged 18 to 45
- diagnosed as HIV+
- receiving care through IDCC with Botswana citizenship
- speak either English or Setswana
- able to provide informed consent
Who cannot join
- unable to provide informed consent
- non-English or Setswana speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women in Botswana
The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will use empirically tested stigma interventions that have shown efficacy for serious mental illness and to adapt these to HIV. Additionally, a novel component of this intervention is the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective stigma reduction agent for other conditions but has not yet been widely used with HIV.
The investigators propose to leverage this middle-income context to conduct a Randomized Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The investigators examine the stigma intervention for outcomes among mothers (including adherence to Antiretroviral therapy [ART] and antenatal treatment), and conduct exploratory birth outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building activities to transfer stigma intervention knowledge will occur throughout the project to enable investigators in Botswana to independently develop stigma interventions, thus serving as a model for other African countries. Finally, this pilot intervention will provide valuable data for future intervention trials to reduce stigma and improve ART adherence.
Read the detailed description
To be completed by University of Botswana Research team:
The investigators will sample from the Dept. of Obstetrics and Gynecology (OB/GYN) at Princess Marina Hospital IDCC. Newly-diagnosed pregnant HIV+ women are referred to OB care at Ministry of Health (MOH) antenatal clinics and receive HIV care at the IDCC for continued ART. To account for expected drop out (~10%), ~220 participants will be recruited. All participants will be randomized to receive MME (the HIV-stigma intervention) or TAU (treatment as usual) from week 28-36 of their pregnancy. The investigators will initiate MME in the antenatal period because the cultural practice of botsetsi (below) could impede implementation post-partum. All participants will have PMTCT by initiation of ART before week 32. Adherence to ART, antenatal and PP care, and viral load testing will be tracked from week 28 of pregnancy to 16 weeks PP (~week 56 for full-term babies).
Procedures. To account for expected drop out (~10%), ~220 participants will be recruited, resulting in MME and TAU groups of ~100 with complete data at week 56. For the MME (intervention) arm, the investigators will enroll 9-10 women per group on a rolling basis to comprise ~12 intervention groups total; ~1 MME group will be initiated per month.
Intervention \& Assessment Procedures. One advantage of our study is that, whenever possible, the investigators augment self-report measures with objective measures from medical records (i.e., for infants, birth-weights, APGAR scores at birth; for antenatal treatment, an Antenatal/delivery record tracking antenatal visits that is filled out by doctors; for ART, CD4 count and Viral load data from the integrated patient management system). Fidelity assessments for each session will be evaluated by Ho-Foster. Control Description: Control condition participants will receive TAU, including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the intervention group.
Follow-up Assessment (Months 18-22): Mothers' Postpartum (PP) adherence (56 weeks) serves as a key outcome. The investigators examine a set of exploratory, infant birth outcomes that may result from improved antenatal care and ART adherence. The investigators use an "Under 5 (years old) card" that is filled out by a doctor to track infant's developmental outcomes which is carried by the mother. Child outcomes include: APGAR score, preterm delivery, mortality (at <16 weeks), birthweight, vaccination record, and mother-to-child-transmission of HIV (MTCT). The investigators will call each participant at 4 months' time and ask to meet in person to review their "Under 5 card" to record infant outcomes at both: a) time of birth; b) 16 weeks PP.
- Conditions
- HIV
- Being tested
- Mothers Moving towards Empowerment (MME)
- Keywords
- HIV, Stigma
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers Moving towards Empowerment (MME)Behavioural
MME integrates 3 components: 1) psychoeducation regarding causes, transmission, and treatment of HIV re how adherence to ART and antenatal care acts to promote health for HIV+ women and PMTCT82,83. We will emphasize ART adherence spanning into PP as a maternal duty to raise a healthy child; 2) challenging stereotypes of HIV+ women, such as promiscuity, that threaten core aspects of being a "good woman" and hinder treatment adherence; 3) coping skills for HIV-related discrimination, i.e., rejection or abandonment by male partners leading to discontinuing treatment adherence and impacts on raising children.
| Study group | Role | What they receive |
|---|---|---|
| Mothers Moving towards Empowerment (MME) | Experimental | The MME intervention arm will complete our 8-session intervention, weekly for 60-70 minutes per session. Homework will be assigned each week and reviewed the next session. Certificates will be issued to participants who complete the intervention. Fidelity assessments for each session will be evaluated by local research personnel. Receives: Behavioral: Mothers Moving towards Empowerment (MME) |
| Treatment As Usual (TAU) | No intervention | Control condition participants will receive Treatment as usual (TAU), including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the MME intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalized Stigma
Assesses extent HIV stereotypes are applied to the self. 18 items. (scale 0-3). Good reliability \& validity
Measured: 7 minutes
Anticipated Stigma
Assesses extent people living with HIV/AIDS (PLWHA) anticipate rejection if HIV disclosed. 10 items. (scale 0-3) Good reliability \& validity
Measured: 4 minutes
Perceived Community Stigma
Assesses extent community members would devalue PLWHA. 20 items (scale: 0-3) Good reliability \& validity
Measured: 8 minutes
Enacted Stigma
Experienced stigma by PWLHA. 28 items. (scale 0-3). Good reliability \& validity
Measured: 10 minutes
Secondary outcomes (6)
APGAR Score
Objective: 0-10 as rated by physician (documented at 5 minutes and 10 minutes)
Measured: 1minute
Pre-term delivery
Objective: Born prior to 37 weeks or 37 weeks and after (Yes/ No). Check hospital record
Measured: 1minute
Mortality
Objective: Mortality (e.g. neonatal, infant mortality) (Yes/No). Check hospital record
Measured: 1minute
Birthweight
Objective: Infant weight in grams (low = <2500 g or normal = >2500 g)
Measured: 1minute
Vaccinations
Objective: from 0-4 visits; Vaccines given at 0, 2, 3, and 4 months (e.g., BCG's, Hep B) (score: 0-3 months)
Measured: 1minute
Infant HIV status
PCR Assay conducted at 6 weeks and reflected in medical record; (Y/N)
Measured: 1minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Mar 2019
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To account for expected drop out (\~10%), \~220 participants will be recruited, resulting in MME and TAU groups of \~100 with complete data by the 56th week following the beginning of pregnancy. For the MME arm, we will enroll 9-10 women per group on a rolling basis to comprise \~12 intervention groups total; \~1 MME group will be initiated per month.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Yang, Ph.D., Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698981
- Sponsor's protocol ID
- TW011084-01
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Poku OB, Ho-Foster AR, Entaile P, Misra S, Mehta H, Rampa S, Goodman M, Arscott-Mills T, Eschliman E, Jackson V, Melese T, Becker TD, Eisenberg M, Link B, Go V, Opondo PR, Blank MB, Yang LH. 'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial. Trials. 2020 Oct 7;21(1):832. doi: 10.1186/s13063-020-04676-6.
PubMed 33028387
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women in Botswana
- ClinicalTrials.gov ID
- NCT03698981
- Acronym / sponsor ID
- TW011084-01
- Conditions
- HIV
- Keywords
- HIV, Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 9 Oct 2018 (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.
The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will use empirically tested stigma interventions that have shown efficacy for serious mental illness and to adapt these to HIV. Additionally, a novel component of this intervention is the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective stigma reduction agent for other conditions but has not yet been widely used with HIV.
The investigators propose to leverage this middle-income context to conduct a Randomized Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The investigators examine the stigma intervention for outcomes among mothers (including adherence to Antiretroviral therapy [ART] and antenatal treatment), and conduct exploratory birth outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building activities to transfer stigma intervention knowledge will occur throughout the project to enable investigators in Botswana to independently develop stigma interventions, thus serving as a model for other African countries. Finally, this pilot intervention will provide valuable data for future intervention trials to reduce stigma and improve ART adherence.
Detailed description
To be completed by University of Botswana Research team:
The investigators will sample from the Dept. of Obstetrics and Gynecology (OB/GYN) at Princess Marina Hospital IDCC. Newly-diagnosed pregnant HIV+ women are referred to OB care at Ministry of Health (MOH) antenatal clinics and receive HIV care at the IDCC for continued ART. To account for expected drop out (~10%), ~220 participants will be recruited. All participants will be randomized to receive MME (the HIV-stigma intervention) or TAU (treatment as usual) from week 28-36 of their pregnancy. The investigators will initiate MME in the antenatal period because the cultural practice of botsetsi (below) could impede implementation post-partum. All participants will have PMTCT by initiation of ART before week 32. Adherence to ART, antenatal and PP care, and viral load testing will be tracked from week 28 of pregnancy to 16 weeks PP (~week 56 for full-term babies).
Procedures. To account for expected drop out (~10%), ~220 participants will be recruited, resulting in MME and TAU groups of ~100 with complete data at week 56. For the MME (intervention) arm, the investigators will enroll 9-10 women per group on a rolling basis to comprise ~12 intervention groups total; ~1 MME group will be initiated per month.
Intervention \& Assessment Procedures. One advantage of our study is that, whenever possible, the investigators augment self-report measures with objective measures from medical records (i.e., for infants, birth-weights, APGAR scores at birth; for antenatal treatment, an Antenatal/delivery record tracking antenatal visits that is filled out by doctors; for ART, CD4 count and Viral load data from the integrated patient management system). Fidelity assessments for each session will be evaluated by Ho-Foster. Control Description: Control condition participants will receive TAU, including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the intervention group.
Follow-up Assessment (Months 18-22): Mothers' Postpartum (PP) adherence (56 weeks) serves as a key outcome. The investigators examine a set of exploratory, infant birth outcomes that may result from improved antenatal care and ART adherence. The investigators use an "Under 5 (years old) card" that is filled out by a doctor to track infant's developmental outcomes which is carried by the mother. Child outcomes include: APGAR score, preterm delivery, mortality (at <16 weeks), birthweight, vaccination record, and mother-to-child-transmission of HIV (MTCT). The investigators will call each participant at 4 months' time and ask to meet in person to review their "Under 5 card" to record infant outcomes at both: a) time of birth; b) 16 weeks PP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- To account for expected drop out (~10%), ~220 participants will be recruited, resulting in MME and TAU groups of ~100 with complete data by the 56th week following the beginning of pregnancy. For the MME arm, we will enroll 9-10 women per group on a rolling basis to comprise ~12 intervention groups total; ~1 MME group will be initiated per month.
| Arm | Type | Receives |
|---|---|---|
| Mothers Moving towards Empowerment (MME) | Experimental | Behavioral: Mothers Moving towards Empowerment (MME)The MME intervention arm will complete our 8-session intervention, weekly for 60-70 minutes per session. Homework will be assigned each week and reviewed the next session. Certificates will be issued to participants who complete the intervention. Fidelity assessments for each session will be evaluated by local research personnel. |
| Treatment As Usual (TAU) | No intervention | –Control condition participants will receive Treatment as usual (TAU), including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the MME intervention group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- primiparous women
- aged 18 to 45
- diagnosed as HIV+
- receiving care through IDCC with Botswana citizenship
- speak either English or Setswana
Key exclusion criteria (2 listed)
- unable to provide informed consent
- non-English or Setswana speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers Moving towards Empowerment (MME)MME integrates 3 components: 1) psychoeducation regarding causes, transmission, and treatment of HIV re how adherence to ART and antenatal care acts to promote health for HIV+ women and PMTCT82,83. We will emphasize ART adherence spanning into PP as a maternal duty to raise a healthy child; 2) challenging stereotypes of HIV+ women, such as promiscuity, that threaten core aspects of being a "good woman" and hinder treatment adherence; 3) coping skills for HIV-related discrimination, i.e., rejection or abandonment by male partners leading to discontinuing treatment adherence and impacts on raising children. | Behavioural | Mothers Moving towards Empowerment (MME) |
Primary outcome
Internalized Stigma
Time frame: 7 minutes
Assesses extent HIV stereotypes are applied to the self. 18 items. (scale 0-3). Good reliability \& validity
Anticipated Stigma
Time frame: 4 minutes
Assesses extent people living with HIV/AIDS (PLWHA) anticipate rejection if HIV disclosed. 10 items. (scale 0-3) Good reliability \& validity
Perceived Community Stigma
Time frame: 8 minutes
Assesses extent community members would devalue PLWHA. 20 items (scale: 0-3) Good reliability \& validity
Enacted Stigma
Time frame: 10 minutes
Experienced stigma by PWLHA. 28 items. (scale 0-3). Good reliability \& validity
6 secondary outcomes
APGAR Score
Time frame: 1minute
Pre-term delivery
Time frame: 1minute
Mortality
Time frame: 1minute
Birthweight
Time frame: 1minute
Vaccinations
Time frame: 1minute
Infant HIV status
Time frame: 1minute
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 Mar 2021.
- Derived from this study: PubMed 33028387Poku OB, Ho-Foster AR, Entaile P, Misra S, Mehta H, Rampa S, Goodman M, Arscott-Mills T, Eschliman E, Jackson V, Melese T, Becker TD, Eisenberg M, Link B, Go V, Opondo PR, Blank MB, Yang LH. 'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial. Trials. 2020 Oct 7;21(1):832. doi: 10.1186/s13063-020-04676-6.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Lawrence Yang, Ph.D. principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers Moving towards Empowerment (MME) in people with HIV, run by New York University at 1 site in Botswana.
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 6 inclusion and 2 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 Mar 2021. 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 Botswana. 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?
Internalized Stigma (time frame: 7 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698981, which also lists 1 linked publication.
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 Mar 2021.