Health TrialsbyHealthPanel

Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

ConditionsSexual Risk Behavior for HIV-infectionReproductive Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Woman

Aged 18 years or older

Have a uterus

Do not have HIV (by self-report)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • PrEP Decision Aid

    Device

    Patient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling.

  • Generic Information

    Other intervention

    Participants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PrEP Decision AidExperimental treatment 1 intervention
Group B: Generic InformationOther 1 intervention

Trial outcomes

Primary outcomes

1

PrEP initiation (prescribing)

Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame

Time frame
6 months
2

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

Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).

Time frame
6 months
3

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

Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.

Time frame
6 months
4

Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)

Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)

Time frame
6 months

Secondary outcomes

1

PrEP initiation (dispensing)

Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame

Time frame
6 months
2

PrEP initiation (first use)

Whether PrEP was started by the patient within the 6 months' time frame (yes/no)

Time frame
6 months
3

PrEP adherence

Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back

Time frame
6 months
4

PrEP adherence

Non-pharmacokinetic: (objective) pharmacy refill data or injection dates for LAI.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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