Brief Cognitive Behavioral Therapy for PrEP Adherence in Pregnant Women

Recruiting at 1 trial location

Overseen By Amelia M Stanton, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must be taking: PrEP

Disqualifiers: Psychotic disorder, Untreated bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cognitive behavioral therapy (CBT) program to help pregnant women in South Africa adhere to their HIV prevention medication, known as PrEP. Many women encounter challenges like stress or depression, which hinder regular PrEP use. Participants will either receive new CBT sessions designed to address these issues and enhance self-care skills or continue with their usual care, referred to as Enhanced Treatment as Usual. Pregnant women who recently started PrEP and have experienced stress or depression might be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could improve HIV prevention strategies for pregnant women.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving adherence to PrEP (a medication to prevent HIV) during pregnancy.

What prior data suggests that this cognitive behavioral intervention is safe for improving PrEP adherence?

Research has shown that brief cognitive behavioral therapy (CBT) is generally safe for pregnant women. Studies have found that CBT can effectively reduce anxiety and depression without causing major side effects. For example, one study found that women who received CBT during pregnancy had much lower anxiety and depression levels. Another study showed that pregnant women who participated in CBT had better relationships and a clearer understanding of their social status, with no serious side effects reported.

While these studies highlight mental health benefits, the absence of major side effects suggests that the treatment is well-tolerated. This is encouraging for the safety of brief CBT sessions aimed at helping pregnant women adhere to their medication plans, such as those for PrEP (pre-exposure prophylaxis for HIV prevention). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief CBT-Based Intervention because it offers a novel approach to improving PrEP adherence among pregnant women. Unlike traditional methods that often focus solely on medication reminders or counseling, this intervention integrates cognitive behavioral therapy (CBT) techniques to address the psychological and behavioral barriers to adherence. By using an adapted version of Life Steps, it aims to equip participants with practical skills and strategies to integrate PrEP into their daily routines more effectively. This could potentially lead to better adherence rates and ultimately improve health outcomes for mothers and their babies.

What evidence suggests that this trial's treatments could be effective for improving PrEP adherence in pregnant women?

This trial will compare a Brief CBT-Based Intervention with Enhanced Treatment as Usual for PrEP adherence in pregnant women. Research has shown that brief cognitive behavioral therapy (CBT) helps pregnant women manage stress, anxiety, and depression. Studies have found that CBT improves relationships and mental health during pregnancy and can prevent depression and anxiety after childbirth. Additionally, CBT remains effective even when provided by non-specialists, increasing its accessibility. Overall, brief CBT has strong potential to support better mental health in pregnant women, which might help them adhere to treatments like PrEP. ^{1 2 6 7 8}

Who Is on the Research Team?

Amelia Stanton, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for pregnant women over the age of 15 in Gugulethu, South Africa, who are HIV-negative and have recently started PrEP or face challenges with PrEP adherence. Participants should show moderate to severe symptoms of posttraumatic stress or depression. Women with significant psychiatric illnesses that could interfere with participation or unable to consent in English/Xhosa are excluded.

Inclusion Criteria

I am female.

Pregnant and presenting antenatal care at the Gugulethu MOU

HIV-negative

Exclusion Criteria

I can provide informed consent 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.

I have no health issues preventing me from traveling to the clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief CBT-based intervention to improve PrEP adherence, consisting of approximately 4 sessions

8 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of depression, PTSD, and PrEP adherence

3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Brief CBT-Based Intervention
• Enhanced Treatment as Usual

Trial Overview The study tests a brief cognitive behavioral therapy (CBT) intervention aimed at reducing psychological barriers like posttraumatic stress and depression to improve adherence to PrEP during pregnancy and breastfeeding. The feasibility and acceptability will be evaluated through interviews and a pilot randomized controlled trial integrated into antenatal care.

How Is the Trial Designed?

Group I: Treatment Condition: Brief CBT-Based Intervention Experimental Treatment 1 Intervention

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.

Group II: Control Condition: Enhanced Treatment as Usual Active Control 1 Intervention

Participants randomized to the control condition (n= 30) will receive enhanced treated as usual.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

University of Cape Town

Collaborator

Trials

257

Recruited

458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a pilot study involving 61 adults interested in PrEP, those receiving strengths-based case management (SBCM) showed a higher rate of completing a provider visit (53.3%) compared to the control group (32.3%), suggesting that SBCM can effectively facilitate access to PrEP care.

Overall, 34% of participants initiated PrEP within 12 weeks, with no significant difference in the time to initiation between the SBCM and control groups, indicating that while SBCM helps with provider visits, it may not speed up the actual start of PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. Doblecki-Lewis, S., Butts, S., Botero, V., et al.[2020]

In a study involving 1172 participants in the iPrEx open-label extension, self-reported recent PrEP dosing was generally reliable, with 84% of participants reporting at least one dose in the past 3 days, and 83% of these having quantifiable drug levels.

However, 82% of those who reported no doses in the past 3 days actually had no detectable drug, indicating a significant discrepancy, particularly among younger individuals and those with lower educational attainment, highlighting the need for better monitoring strategies for PrEP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. Amico, KR., Mehrotra, M., Avelino-Silva, VI., et al.[2019]

A study involving 603 adolescent girls and young women in South Africa identified that external factors like school schedules and social conflicts, such as partner mistrust, significantly contribute to breaks in daily oral PrEP use.

Social support and familiarity with PrEP were crucial for re-initiating use, suggesting that long-acting injectable PrEP could help overcome barriers to consistent adherence and improve overall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. de Vos, L., Mudzingwa, EK., Fynn, L., et al.[2023]

Pregnant women in Malawi showed strong motivation to use PrEP for HIV protection for themselves and their unborn child, despite concerns about safety, side effects, and stigma, indicating a high level of acceptance of PrEP during pregnancy.

Most women felt positively about their decision to start PrEP, but those with more concerns, particularly about partner disclosure and pill attributes, experienced greater decisional regret, suggesting the need for supportive counseling strategies that address these concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study. Hill, LM., Golin, CE., Saidi, F., et al.[2023]

A study involving 25 postpartum women who adhered to PrEP (pre-exposure prophylaxis) revealed that strong HIV risk perception and the desire to have an HIV-free baby were key motivators for consistent use.

Support from partners and family, along with effective communication about PrEP, significantly enhanced adherence, while stigma and side effects were common barriers that could be managed with education and strategic planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa. Joseph Davey, DL., Knight, L., Markt-Maloney, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8220301/

Brief cognitive behavioral therapy in pregnant women at ... Brief CBT in pregnancy was effective in preventing PPD. CBT improved interpersonal relationships and understanding of social status (OQ-45).

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04547-9

a systematic review and meta-analysis - BMC Psychiatry Findings from this meta-analysis demonstrate that CBT-based interventions for perinatal depression are effective both during pregnancy and the ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/10/4/e037590

Cognitive–behavioral therapy-based intervention to treat ... Dissemination Results from this trial will build evidence for the efficacy of a CBT-based intervention for pregnant women delivered by non-specialised providers ...

4. researchgate.net researchgate.net/publication/6340662_Brief_antenatal_cognitive_behaviour_therapy_group_intervention_for_the_prevention_of_postnatal_depression_and_anxiety_A_randomised_controlled_trial

Brief antenatal cognitive behaviour therapy group ... Analyses on the 132 "completers" showed significant symptomatic improvement over time for both the CBT group and control condition. Depression ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8224503/

The effect of cognitive–behavioral counseling of pregnant ... Cognitive–behavioral group counseling can be effective as an approach in improving the symptoms of stress, anxiety, and depression in pregnant women.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666915321001219

Group cognitive-behavioural therapy for perinatal anxiety ... Results: Results showed participants experienced significant reductions in anxiety and depression from pre- to post-treatment. Patients reported high ratings of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9368246/

The Efficacy of Digital Cognitive–Behavioral Interventions ... The present meta-analysis investigated the overall and differential efficacy of digital cognitive–behavioral therapies (CBTs) vs. third-generation CBTs ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06640608

Study Details | NCT06640608 | Internet- Based Cognitive ... Pregnant women who receive an internet -based Cognitive Behavioral Therapy education report a significant change in a mean scores of fear of childbirth than ...