HIV InfectionsPrEPNCT04071470
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
A study testing Storytelling and PrEP in people with HIV Infections, run by Vanderbilt University Medical Center at 1 site in Mozambique.
Trial summary
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women. The purpose of this proposal is to evaluate the clinical impact and mechanisms of a family-based storytelling intervention (vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Storytelling and PrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Jan 2021to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women/male partner
- Discordant couple, one pregnant woman (HIV-) and her HIV+ male partner
- Both persons must agree to take PrEP (pregnant woman)/ART (male partner)
- The woman's due date is >4 weeks from study enrollment
- Both persons must be 18 years or older
- Both persons (parents) must be willing to consent to an infant record search
Show all 13Show fewer
- Neither member of the couple can be under the influence of alcohol at the time of consent.
- Family members of expectant couple
- Must be a relative living in the participants household or living in the study community
- Must agree to participate in at least one of the storytelling sessions;
- Must be 18 years of age or older
- Must not be under the influence of alcohol
- Must be willing to participate in the interview.
Who cannot join
- Pregnant woman/Male Partner
- 1. One member of the couple is unwilling to enroll in treatment
- Family members
- Unable to attend storytelling session
- Expectant couple expresses unwillingness for the family member to participate
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
Minisitry of Health Health Facility
Quelimane, Zambezia Province
About this study
Official title: Increasing Family-based Support for PrEP Adherence Among Discordant Couples Through Storytelling
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women. The purpose of this proposal is to evaluate the clinical impact and mechanisms of a family-based storytelling intervention (vs. couples counseling) to improve PrEP adherence and retention among at-risk pregnant/lactating women and their HIV-infected male partners in rural Mozambique. This potentially high impact intervention provides the opportunity to test a culturally relevant approach to PrEP engagement; if proven feasible and effective, family-based storytelling for PrEP engagement could be adopted to reduce HIV incidence among pregnant/lactating women and eliminate mother-to-child transmission (MTCT).
Read the detailed description
Project Summary: Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition. HIV acquisition is of particular concern during pregnancy and while the mother is breastfeeding given the associated increased risk of mother-to-child transmission (MTCT). Approximately 10% of pregnant women attending antenatal care (ANC) in Mozambique are in serodiscordant relationships (HIV-negative woman/ HIV-positive man). High rates of MTCT (14%; 12,000 infants/ year) may be affected by the high rate at which pregnant women seroconvert after their first ANC visit. Beginning in 2018, pre-exposure prophylaxis (PrEP) was available to serodiscordant couples, yet only 44% of pregnant women were retained in care at 3 months.
Our current R01-funded project, Partners-based HIV Treatment for Seroconcordant Couples (R01MH113478), is testing a couple-based intervention for HIV-positive expectant parents living in extremely rural communities. Our Men for Health intervention ("Homens para Saúde+"- HoPS+) consists of (1) couple-based HIV care and treatment; (2) couple-centered education; and (3) expert-patient support. Preliminary data the HoPS+ study suggest that couple-based counseling and education is more successful at reducing maternal depression than individual care. However, couple-based sessions have not led to significantly greater improvements in HIV knowledge or social support. Given the importance of these factors on treatment adherence, this grant would allow us to revise the peer engagement strategy to increase knowledge transfer and engender partner support.
The investigators propose testing the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, PrEP/ART among expectant serodiscordant couples. People are 7 times more likely to remember a story compared to facts alone. Couples are also highly influenced by their immediate and extended families; >95% of patients disclose their HIV status to members of their family. The investigators hypothesize that the use of oral storytelling will facilitate learning and encourage family support and advocacy. The investigator will compare this model to couple-based education and counseling. This innovative intervention tests a culturally relevant approach to improve ART/PrEP delivery. The investigators propose a rigorous individually randomized controlled trial at one of our current HoPS+ sites where 11% of expectant couples were serodiscordant in 2018. The investigators will randomize 70 HIV-uninfected pregnant women and 70 of their HIV-infected partners (total 140) to either the intervention or control condition.
The Specific Aims of this study are: (1) Compare the effect of a storytelling intervention (vs. couples-based counseling) on participant knowledge, motivation, and behavioral skills associated with PrEP retention and adherence; and (2) Evaluate the impact of a storytelling intervention on adherence to PrEP/ART medications. Our team of Mozambican and U.S. investigators has a proven record of international HIV research success, specific recent experience with partner-based HIV and PrEP delivery, and experience with the use of theater/storytelling to change HIV-related behaviors.
- Conditions
- HIV Infections
- Being tested
- Storytelling, PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StorytellingBehavioural
Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP
PrEPDrug
Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men) Receives: Drug: PrEP |
| Storytelling Intervention | Experimental | Participants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services. Receives: Behavioral: Storytelling; Drug: PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PrEP Medication
Maternal adherence to medication as measured via monthly medication pick up records
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will be comparing standard of care PrEP services with a storytelling intervention arm
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Friends in Global Health
- Responsible party
- Principal investigator, Carolyn Audet, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071470
- Sponsor's protocol ID
- storytelling
- Acronym
- PrEP
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2019
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sack DE, De Schacht C, Paulo P, Graves E, Emilio AM, Matino A, Fonseca CL, Aboobacar AU, Van Rompaey S, Audet CM. Pre-exposure prophylaxis use among HIV serodiscordant couples: a qualitative study in Mozambique. Glob Health Action. 2021 Jan 1;14(1):1940764. doi: 10.1080/16549716.2021.1940764.
PubMed 34229580
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Family-based Support for PrEP Adherence Among Discordant Couples Through Storytelling
- ClinicalTrials.gov ID
- NCT04071470
- Acronym / sponsor ID
- PrEP / storytelling
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Friends in Global Health
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women. The purpose of this proposal is to evaluate the clinical impact and mechanisms of a family-based storytelling intervention (vs. couples counseling) to improve PrEP adherence and retention among at-risk pregnant/lactating women and their HIV-infected male partners in rural Mozambique. This potentially high impact intervention provides the opportunity to test a culturally relevant approach to PrEP engagement; if proven feasible and effective, family-based storytelling for PrEP engagement could be adopted to reduce HIV incidence among pregnant/lactating women and eliminate mother-to-child transmission (MTCT).
Detailed description
Project Summary: Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition. HIV acquisition is of particular concern during pregnancy and while the mother is breastfeeding given the associated increased risk of mother-to-child transmission (MTCT). Approximately 10% of pregnant women attending antenatal care (ANC) in Mozambique are in serodiscordant relationships (HIV-negative woman/ HIV-positive man). High rates of MTCT (14%; 12,000 infants/ year) may be affected by the high rate at which pregnant women seroconvert after their first ANC visit. Beginning in 2018, pre-exposure prophylaxis (PrEP) was available to serodiscordant couples, yet only 44% of pregnant women were retained in care at 3 months.
Our current R01-funded project, Partners-based HIV Treatment for Seroconcordant Couples (R01MH113478), is testing a couple-based intervention for HIV-positive expectant parents living in extremely rural communities. Our Men for Health intervention ("Homens para Saúde+"- HoPS+) consists of (1) couple-based HIV care and treatment; (2) couple-centered education; and (3) expert-patient support. Preliminary data the HoPS+ study suggest that couple-based counseling and education is more successful at reducing maternal depression than individual care. However, couple-based sessions have not led to significantly greater improvements in HIV knowledge or social support. Given the importance of these factors on treatment adherence, this grant would allow us to revise the peer engagement strategy to increase knowledge transfer and engender partner support.
The investigators propose testing the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, PrEP/ART among expectant serodiscordant couples. People are 7 times more likely to remember a story compared to facts alone. Couples are also highly influenced by their immediate and extended families; >95% of patients disclose their HIV status to members of their family. The investigators hypothesize that the use of oral storytelling will facilitate learning and encourage family support and advocacy. The investigator will compare this model to couple-based education and counseling. This innovative intervention tests a culturally relevant approach to improve ART/PrEP delivery. The investigators propose a rigorous individually randomized controlled trial at one of our current HoPS+ sites where 11% of expectant couples were serodiscordant in 2018. The investigators will randomize 70 HIV-uninfected pregnant women and 70 of their HIV-infected partners (total 140) to either the intervention or control condition.
The Specific Aims of this study are: (1) Compare the effect of a storytelling intervention (vs. couples-based counseling) on participant knowledge, motivation, and behavioral skills associated with PrEP retention and adherence; and (2) Evaluate the impact of a storytelling intervention on adherence to PrEP/ART medications. Our team of Mozambican and U.S. investigators has a proven record of international HIV research success, specific recent experience with partner-based HIV and PrEP delivery, and experience with the use of theater/storytelling to change HIV-related behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will be comparing standard of care PrEP services with a storytelling intervention arm
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: PrEPStandard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men) |
| Storytelling Intervention | Experimental | Behavioral: Storytelling, Drug: PrEPParticipants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pregnant women/male partner
- Discordant couple, one pregnant woman (HIV-) and her HIV+ male partner
- Both persons must agree to take PrEP (pregnant woman)/ART (male partner)
- The woman's due date is >4 weeks from study enrollment
- Both persons must be 18 years or older
Key exclusion criteria (5 listed)
- Pregnant woman/Male Partner
- 1. One member of the couple is unwilling to enroll in treatment
- Family members
- Unable to attend storytelling session
- Expectant couple expresses unwillingness for the family member to participate
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 |
|---|---|---|
| StorytellingCouples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP | Behavioural | Storytelling Intervention |
| PrEPPatients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC | Drug | Standard of Care, Storytelling Intervention |
Primary outcome
Adherence to PrEP Medication
Time frame: 3 months
Maternal adherence to medication as measured via monthly medication pick up records
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34229580Sack DE, De Schacht C, Paulo P, Graves E, Emilio AM, Matino A, Fonseca CL, Aboobacar AU, Van Rompaey S, Audet CM. Pre-exposure prophylaxis use among HIV serodiscordant couples: a qualitative study in Mozambique. Glob Health Action. 2021 Jan 1;14(1):1940764. doi: 10.1080/16549716.2021.1940764.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling and PrEP in people with HIV Infections, run by Vanderbilt University Medical Center at 1 site in Mozambique.
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 13 inclusion and 5 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 25 Jul 2024. 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 Mozambique. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to PrEP Medication (time frame: 3 months). 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 NCT04071470, 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 25 Jul 2024.