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Behavioural Intervention

PrEP Counseling for HIV Prevention

N/A

Waitlist Available

Led By Sangini S Sheth, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently on PrEP

Do not have HIV (by self-report)

Must not have

People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)

People who wish to become pregnant (will not qualify for contraceptive counseling)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial focuses on the importance of combining HIV prevention with contraceptive counseling during family planning clinic visits.

Who is the study for?

This trial is for English or Spanish-speaking cis-women aged 18+ with a uterus, who are not HIV positive, not on PrEP, and seeking contraceptive counseling at participating clinics. It's also for clinic staff involved in patient care. Those planning pregnancy or have had certain surgeries won't qualify.

What is being tested?

The study is testing whether integrating an HIV prevention tool called 'PrEP Decision Aid' into family planning clinics' contraceptive counseling can help prevent HIV. Participants will receive either this decision aid or generic information to compare effectiveness.

What are the potential side effects?

Since the interventions involve informational tools rather than medications, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently taking medication to prevent HIV.

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I do not have HIV.

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I am a woman over 18 with a uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot become pregnant due to surgery.

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I plan to become pregnant and do not need contraceptive counseling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)

Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)

Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy

+2 more

Secondary study objectives

PrEP adherence

PrEP initiation (dispensing)

PrEP initiation (first use)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PrEP Decision AidExperimental Treatment1 Intervention

Participants randomized to the decision aid (active intervention arm), will interact with the enhanced PrEP decision aid in REDCap. This is an individualized, patient-facing decision aid that supports informed patient choice and is interactive. In contrast to shared decision aids that guide a clinical encounter, the participants uses the individualized decision aid prior to the clinical encounter to discretely assess HIV risk and build awareness before discussing with their clinician

Group II: Generic InformationExperimental Treatment1 Intervention

Participants randomized to this arm will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis)" (available online free of charge through CDC website) that will serve as a time- and attention-based control.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PrEP Decision Aid

2017

N/A

~90

0 / 5Eligibility criteria met