Supporting Oral and Long-acting PrEP Decision Making Among Pregnant Women in Lilongwe, Malawi

NCT ID: NCT06397690

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-07-16

Brief Summary

Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about Pre-exposure prophylaxis (PrEP) use during pregnancy and breastfeeding.

Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period. Investigators will recruit 50 women to participate in the feasibility pilot study. A subset of these participants will participate in qualitative interviews. Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews.

Procedures (methods): Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, Long-acting injectable cabotegravir (CAB-LA), and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.

Detailed Description

Study design:

Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, CAB-LA, and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.

Study intervention:

The study intervention, My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP. The intervention counseling will be delivered by trained study staff with a background in psychosocial counseling. The intervention consists of counseling facilitated by a SDM tool. The woman's partner may be present depending on her preference. It begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. After understanding participant HIV risk and desire for HIV protection, the counselor presents HIV prevention options including CAB-LA, daily oral PrEP, and internal and external condoms (discussing attributes and potential advantages and disadvantages of each method). This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant (product attributes and personal and interpersonal implications of each method). The counselor reviews information about these valued features for each offered method. This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred method(s).

Standard of care (control arm):

Participants randomized to the control arm will PrEP counseling as based on the current standard of care (SOC) . The SOC counseling will be delivered by a trained study staff member. The SOC counselor PrEP counseling according to national guidelines. Per current guidelines, the SOC counseling may include the following elements: An HIV risk assessment according to PrEP eligibility criteria; discussion of a combination prevention approach (PrEP and condoms) and risk reduction strategies. The women will receive comprehensive education on both the advantages and limitations of PrEP, including guidance on managing potential side effects. Subsequently, the counselor will assess the woman's eligibility, willingness, and readiness to start using PrEP. Women choosing oral PrEP during the SOC counseling session will be referred to government services to initiate PrEP. Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program.

Participants will be randomly assigned 1:1 to one of two study arms (intervention or comparison) using permuted block randomization. Participants will be blinded to their assignment, but study staff will not.

Participants choosing oral PrEP during the counselling session in either intervention or comparison arm will receive an assisted referral to government PrEP services at the study site to initiate their selected PrEP method per national guidelines. Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program. No study drug will be administered. Initiation of either PrEP method (i.e., receipt of prescription or injection) will be confirmed through clinic or pharmacy records, as well as information on reasons for non-initiation if applicable.

Investigators plan study follow-up visits at month 1 and month 2 following enrollment. Interviewer-administered questionnaires will be completed at the month 1 follow-up and the final follow-up visit (month 2). Questionnaires will assess study outcomes and associated social and behavioural measures to contextualize understanding of primary study outcomes. A subset of participants will complete in-depth qualitative interviews at month 1. Interviews will provide additional understanding of participant experiences with the intervention and experience using PrEP (if applicable).

Conditions

HIV Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

My Choice for HIV Prevention (MyChoice)

The MyChoice intervention consists of PrEP shared decision-making counseling delivered by a trained counselor. It begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including CAB-LA, daily oral PrEP, and internal and external condoms (discussing attributes and potential advantages and disadvantages of each method). This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant (product attributes and personal and interpersonal implications of each method). The counselor reviews information about these valued features for each offered method. This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred method(s).

Group Type: EXPERIMENTAL

My Choice for HIV Prevention (MyChoice)

Intervention Type: BEHAVIORAL

My Choice for HIV Prevention (MyChoice) is a counselor-delivered shared decision-making approach for pregnant women considering PrEP

Standard of care (control arm)

Participants randomized to the control arm will receive PrEP counseling as based on the current standard of care (SOC). The SOC counseling will be delivered by a trained study staff member. The SOC counselor PrEP counseling according to national guidelines. Control arm participants will receive comprehensive education on both the advantages and limitations of each PrEP method, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using PrEP.

Group Type: ACTIVE_COMPARATOR

Standard of care (control arm)

Intervention Type: BEHAVIORAL

Standard of care (control arm) participants will receive comprehensive education on both the advantages and limitations of each PrEP method, including guidance on potential side effects.

Interventions

My Choice for HIV Prevention (MyChoice)

My Choice for HIV Prevention (MyChoice) is a counselor-delivered shared decision-making approach for pregnant women considering PrEP

Intervention Type: BEHAVIORAL

Standard of care (control arm)

Standard of care (control arm) participants will receive comprehensive education on both the advantages and limitations of each PrEP method, including guidance on potential side effects.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

The criteria for pregnant women participants is as follows:

• Age 18 or older
• Documented pregnancy by urine pregnancy test or physical exam
• Documented negative HIV status within the past three months
• Identified factor(s) for elevated risk for HIV acquisition per PrEP national eligibility guidelines
• Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
• Ability and willingness to provide informed consent

Investigators will also conduct interviews with male partners and study staff to assess exploratory qualitative outcomes. All study staff will be eligible to participate in an interview. Male partners will be eligible to participate if they meet the following criteria:

• Referred by a study participant as her romantic partner
• Age 18 or older
• Able and willing to provide informed consent

Exclusion Criteria

• Positive HIV test at time of screening
• No identified HIV risk factors per national PrEP guidelines
• Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Hill, PhD,MSPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Bwaila Hospital

Lilongwe, Central Region, Malawi

Countries

Malawi

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AI050410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0511

Identifier Type: -

Identifier Source: org_study_id