DepressionNCT05624931
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
A study testing Brief CBT-Based Intervention and Enhanced Treatment as Usual in people with Depression and Posttraumatic Stress Disorder, run by Boston University Charles River Campus at 2 sites in 2 countries.
Trial summary
Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Posttraumatic Stress Disorder, Pregnancy Related
- What is being tested?
- Brief CBT-Based Intervention and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Apr 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For participants across all three aims are:
- Female sex
- Aged 15+
- Pregnant and presenting antenatal care at the Gugulethu MOU
- HIV-negative
- Recent PrEP initiation (<1 month ago) or PrEP adherence challenges, either documented (>2 weeks late to pick up PrEP refill) or self-reported
- Moderate to severe symptoms of posttraumatic stress and/or depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment.
Who cannot join
- There are no exclusion criteria with respect to parity or gravidity.
- Participants who are unable to provide informed consent or assent in English or Xhosa
- Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants.
- Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Boston University
Boston, Massachusetts, 02215
Amelia M Stanton, PhD, 617-353-2580, stantona@bu.edu
Madison R Fertig, MA, 617-358-1374, mrfertig@bu.edu
South Africa1 site, 1 recruiting
- Recruiting
Gugulethu Midwife Obstetric Unit (MOU)
Cape Town, Western Cape, 8001
Lucia Knight, PhD, 021-650-5313, lucia.knight@uct.ac.za
About this study
Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.
- Being tested
- Brief CBT-Based Intervention, Enhanced Treatment as Usual
- Keywords
- HIV, pregnancy, PrEP
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief CBT-Based InterventionBehavioural
Aims 1 (n=30) and 2 (n=18) will inform the Aim 3 intervention. We anticipate that the intervention will be comprised of four treatment sessions. These sessions will likely target two pathways to PrEP adherence and persistence: (1) decreased withdrawal and avoidance and (2) behavioral skill building to increase self-care/health behaviors. To decrease withdrawal and avoidance, we will likely include CBT-based exercises that improve distress tolerance and coping. To help participants build new behavioral skills, we will likely incorporate behavioral activation and problem-solving. Behavioral activation is a CBT strategy that promotes scheduling activities that align with an individual's values, which will also break maladaptive patterns of withdrawal and avoidance. Problem-solving is an empirically-supported treatment for depression; training patients to problem-solve adaptively will help them "approach" PrEP use by navigating barriers.
Enhanced Treatment as UsualOther
This is the control intervention. Participants will receive antenatal care as usual, which is monthly visits to the MOU, information about using PrEP during pregnancy (information sheet or pamphlet), and a psychological services referral.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Condition: Brief CBT-Based Intervention | Experimental | This group (n=30) will be guided through an adaptation of Life Steps, a single-session, cognitive behavioral therapy (CBT)-based medication adherence intervention that has been used to increase PrEP adherence. Participants will also receive four additional intervention sessions. Receives: Behavioral: Brief CBT-Based Intervention |
| Control Condition: Enhanced Treatment as Usual | Active comparator | Participants randomized to the control condition (n= 30) will receive enhanced treated as usual. Receives: Other: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Feasibility will be assessed by (1) interventionist fidelity to the protocol, (2) treatment session attendance, and (3) participant retention at 3-months postpartum (T3). Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions addressed 90% of the key session components, (2) 75% of the participants (at least 23 of 30) attended at least two of the four treatment sessions; and (3) 60% of the participants (at least 18 of 30) completed the three-month postpartum assessment (T3). To measure fidelity, we will review 20% of the session audio-recordings randomly selected from each of the four sessions and determine whether key session components were addressed.
Measured: This will be assessed at 2 months post-baseline
Acceptability
Acceptability will be assessed (1) in the qualitative exit interviews and (2) with the brief acceptability questionnaire completed after each intervention session. Acceptability data from the qualitative exit interviews will be described, and the intervention will be deemed acceptable if at least 75% of the participants rate three or more of the items on the acceptability questionnaires with "high satisfaction" (4 or 5 on the Likert-style scale).
Measured: This will be assessed at 2 months post-baseline
Secondary outcomes (4)
PrEP Adherence
PrEP adherence during the previous week will be assessed at the end of the intervention/2 months post-baseline (T2) and at 3-months postpartum (T3) via an adapted version of the Wilson three-item self-report adherence scale, which includes (1) number of missed doses, (2) the percentage of time that PrEP was taken as prescribed, and (3) a rating of one's ability to take PrEP.
Measured: This will be assessed at 2 months post-baseline and at 3 months postpartum
PrEP Persistence
PrEP persistence at T2 and T3 will be determined via dried blood spot (DBS) testing and defined as tenofovir- diphosphate (TVF-DP) concentrations of at least 650 fmol/punch for pregnant women and 1050 fmol/punch for postpartum women, which are indicative of 7 doses per week over a period of up to eight weeks.
Measured: This will be assessed at 2 months post-baseline and at 3 months postpartum
Posttraumatic Stress Disorder (PTSD)
Changes in PTSD symptom severity from baseline will be measured using the PTSD Checklist for DSM-5 (PCL-5). A cutoff score of ≥31 will be used to determine moderate or severe PTSD symptoms.
Measured: This will be assessed at 2 months post-baseline and at 3 months postpartum
Depression
Changes in depression from baseline will be measured using the Edinburgh Postnatal Depression Scales. A cutoff score of ≥13 will be used to determine moderate or severe depression symptoms.
Measured: This will be assessed at 2 months post-baseline and at 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start17 Apr 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aims 1 and 2 will assess a single group of pregnant women. In Aim 3, a randomized control trial will include an intervention group and control group that are running in parallel.
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Amelia Stanton, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624931
- Sponsor's protocol ID
- 6783E
- Other IDs
- K23MH131438
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
- ClinicalTrials.gov ID
- NCT05624931
- Acronym / sponsor ID
- 6783E
- Keywords
- HIV, pregnancy, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Nov 2022 (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.
Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aims 1 and 2 will assess a single group of pregnant women. In Aim 3, a randomized control trial will include an intervention group and control group that are running in parallel.
| Arm | Type | Receives |
|---|---|---|
| Treatment Condition: Brief CBT-Based Intervention | Experimental | Behavioral: Brief CBT-Based InterventionThis group (n=30) will be guided through an adaptation of Life Steps, a single-session, cognitive behavioral therapy (CBT)-based medication adherence intervention that has been used to increase PrEP adherence. Participants will also receive four additional intervention sessions. |
| Control Condition: Enhanced Treatment as Usual | Active comparator | Other: Enhanced Treatment as UsualParticipants randomized to the control condition (n= 30) will receive enhanced treated as usual. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- For participants across all three aims are:
Key exclusion criteria (4 listed)
- There are no exclusion criteria with respect to parity or gravidity.
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 |
|---|---|---|
| Brief CBT-Based InterventionAims 1 (n=30) and 2 (n=18) will inform the Aim 3 intervention. We anticipate that the intervention will be comprised of four treatment sessions. These sessions will likely target two pathways to PrEP adherence and persistence: (1) decreased withdrawal and avoidance and (2) behavioral skill building to increase self-care/health behaviors. To decrease withdrawal and avoidance, we will likely include CBT-based exercises that improve distress tolerance and coping. To help participants build new behavioral skills, we will likely incorporate behavioral activation and problem-solving. Behavioral activation is a CBT strategy that promotes scheduling activities that align with an individual's values, which will also break maladaptive patterns of withdrawal and avoidance. Problem-solving is an empirically-supported treatment for depression; training patients to problem-solve adaptively will help them "approach" PrEP use by navigating barriers. | Behavioural | Treatment Condition: Brief CBT-Based Intervention |
| Enhanced Treatment as UsualThis is the control intervention. Participants will receive antenatal care as usual, which is monthly visits to the MOU, information about using PrEP during pregnancy (information sheet or pamphlet), and a psychological services referral. | Other | Control Condition: Enhanced Treatment as Usual |
Primary outcome
Feasibility of Intervention
Time frame: This will be assessed at 2 months post-baseline
Feasibility will be assessed by (1) interventionist fidelity to the protocol, (2) treatment session attendance, and (3) participant retention at 3-months postpartum (T3). Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions addressed 90% of the key session components, (2) 75% of the participants (at least 23 of 30) attended at least two of the four treatment sessions; and (3) 60% of the participants (at least 18 of 30) completed the three-month postpartum assessment (T3). To measure fidelity, we will review 20% of the session audio-recordings randomly selected from each of the four sessions and determine whether key session components were addressed.
Acceptability
Time frame: This will be assessed at 2 months post-baseline
Acceptability will be assessed (1) in the qualitative exit interviews and (2) with the brief acceptability questionnaire completed after each intervention session. Acceptability data from the qualitative exit interviews will be described, and the intervention will be deemed acceptable if at least 75% of the participants rate three or more of the items on the acceptability questionnaires with "high satisfaction" (4 or 5 on the Likert-style scale).
4 secondary outcomes
PrEP Adherence
Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum
PrEP Persistence
Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum
Posttraumatic Stress Disorder (PTSD)
Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum
Depression
Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- 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.
Amelia Stanton, PhD principal investigator
Boston University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief CBT-Based Intervention and Enhanced Treatment as Usual in people with Depression and Posttraumatic Stress Disorder, run by Boston University Charles River Campus at 2 sites in 2 countries.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia M Stanton, PhD (617-353-2580, stantona@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: This will be assessed at 2 months post-baseline). 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 17 Jul 2026.