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

Trial Summary

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 data supports the effectiveness of the treatment Brief CBT-Based Intervention for PrEP adherence in pregnant women?

Research shows that adherence to PrEP (a medication to prevent HIV) is crucial for its effectiveness, and strategies like psychoeducation and community outreach can help improve adherence. Additionally, support from partners and family, as well as education about PrEP, have been identified as important factors in helping pregnant women stick to their PrEP regimen. ^{1 2 3 4 5}

Is Brief Cognitive Behavioral Therapy for PrEP Adherence in Pregnant Women safe?

The research indicates that PrEP (pre-exposure prophylaxis) is generally safe, though pregnant women may experience temporary side effects. These side effects can often be managed by adjusting the timing of the medication, such as taking it at night. ^{2 3 4 6 7}

How does the Brief CBT-Based Intervention treatment differ from other treatments for PrEP adherence in pregnant women?

The Brief CBT-Based Intervention is unique because it focuses on cognitive behavioral therapy (CBT) techniques to improve adherence to PrEP (pre-exposure prophylaxis) in pregnant women, addressing psychological and behavioral factors that influence adherence, unlike standard PrEP treatments that primarily focus on medication adherence without behavioral support. ^{3 4 8 9 10}

What is the purpose of this trial?

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.

Research Team

Amelia Stanton, PhD

Principal Investigator

Boston University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence to Pre-Exposure Prophylaxis in Adolescents and Young Adults: A Systematic Review and Meta-Analysis. [2022]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

State of the science of adherence in pre-exposure prophylaxis and microbicide trials. [2021]

5. United States 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Low PrEP adherence despite high retention among transgender women in Brazil: the PrEParadas study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis for the prevention of HIV transmission to women. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: a cohort study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study. [2023]