Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi

HIV Prevention Clinical Trial

Official title:

UNCPM 22323 - Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394323
• Other study ID #: 23-3102
• Secondary ID: K01MH121186
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Lauren Hill, PhD, MSPH
• Phone: (919) 966-3761
• Email: hilllm[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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. 100 HIV-negative pregnant women will be recruited to participate in the pilot study. A subset of these participants will participate in qualitative interviews. Up to 20 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews.

Procedures (methods): 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. Investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in oral PrEP will be referred to government PrEP services.

Description:

Study design:

This is a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. Investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in oral PrEP will be referred to government PrEP services.

Study intervention (intervention arm):

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 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). The participant may defer or decline the decision and may request a follow-up counseling visit to take more time to consider her preference or return with a partner or other supporter. If and when a decision is made, the counselor provides post-decision counseling including adherence counseling and disclosure counseling if desired.

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.

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. Initiation of oral PrEP (i.e., receipt of prescription) will be confirmed through clinic or pharmacy records, as well as information on reasons for non-initiation if applicable.

Follow-up:

Participants will complete follow-up visits at month 1, month 2, and month 3. Study visits will be scheduled to align with antenatal care (ANC)/pharmacy visits whenever possible to minimize the number of trips needed at the clinic.

Interviewer-administered questionnaires will be completed at the month 1 and month 3 follow-up visits. 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).

At each follow-up visit, women who have chosen oral PrEP will undergo adherence assessment through self-report and pill counts. Furthermore, investigators will collect dried blood spots (DBS) at month 2 to assess adherence among all oral PrEP users (see below).

Biological specimen collection and testing:

To assess quantify drug concentrations to assess PrEP adherence among participants taking up oral PrEP, a participant blood specimen will be collected via venipuncture at the for applicable participants (those using oral PrEP). This specimen will be used to create a dried blood spot (DBS) specimen at the local designated laboratory, prior to storage and shipment to the reference pharmacology laboratory for testing.

All samples will be obtained from study participants by trained study staff according to approved standard operating procedures. All samples will be processed according to the assay manufacturers' specifications. Specimens will be transported, processed, and temporarily housed at UNC Project Malawi (UNCPM) (Lilongwe, Malawi) and shipped to University of North Carolina (UNC) Chapel Hill for analysis. All laboratory testing will be performed by trained staff using standard operating procedures and according to specific assay manufacturers' specifications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The criteria for pregnant women participants is as follows:

Inclusion criteria

• 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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• Behavioral: 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

Locations

Country	Name	City	State
Malawi	Bwaila Hospital	Lilongwe	Central Region

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Intervention Measure Score	Intervention acceptability will be defined as the extent to which participants perceive the intervention to be agreeable, palatable, or satisfactory. Acceptability will be assessed through participant self-report using a validated 4-item scale. This scale measures how agreeable and satisfactory women find the intervention (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate greater acceptability.	enrollment visit, month 2 follow up visit
Primary	Intervention Appropriateness Measure Score	Intervention appropriateness will be defined as the perceived relevance and usefulness of the intervention to support decision making about HIV prevention methods. Appropriateness will be assessed through self-report using a validated 4-item scale to measure women's perceptions of its relevance and usefulness (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate greater appropriateness.	enrollment visit, month 2 follow up visit
Primary	Feasibility of Intervention Measure Score	Intervention feasibility will be defined as extent to which the intervention is perceived to be feasible or practical. Feasibility will be assessed through self-report using a validated 4-item scale to measure women's perceptions of its practicability and ease of use (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate greater feasibility.	enrollment visit, month 2 follow up visit
Secondary	Decisional Conflict Scale Score	A validated scale (Decisional Conflict Scale) will be utilized to assess participants' perceptions decisional conflict regarding the decision whether to use PrEP following receipt of intervention or standard of care counseling. The 16 items in the scale assesses these perceptions by asking participants to rate statements regarding their perceived level of uncertainty, satisfaction, clarity of personal values, and support for decision-making. Responses are rated on a 5-point Likert scale ranging from "Strongly agree" (0) to "Strongly Disagree" (4). Scale scores range from 0 to 100 points (mean item rating multiplied by 25), with higher scores indicating a higher level of decisional conflict.	enrollment visit