Health Trials

DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana

ConditionsHIV InfectionsContraceptionPrEP
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.

The study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Currently using or eligible for PrEP

18 years of age or older

Participated in the parent Tshireletso study in Botswana

Disqualifiers

None

Trial population

Current PrEP users, providers or clinic administrators, and policy makers or program leaders related to PrEP usage in AL and Botswana

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational cohort (PrEP use in real-world settings)

    Other intervention

    No intervention

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Group 1: Adults Using or Eligible for PrEP1 intervention
Group B: Group 2: PrEP Providers and Clinic Administrators1 intervention
Group C: Group 3: Policy Makers and Program Leaders1 intervention

Trial outcomes

Primary outcomes

1

PrEP Continuation (Aim 2)

Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.

Time frame
Up to 2 years

Secondary outcomes

1

PrEP Initiation (Aim 1)

To determine the number and proportion of participants in the PrEP clinic who initiate PrEP.

Time frame
Within 2 years after the initial PrEP clinic visit
2

PrEP Switching (Aim 3)

Among participants who initiate PrEP, to determine the number and proportion who switch between PrEP modalities.

Time frame
Up to 2 years
3

PrEP Discontinuation (Aim 4)

Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.

Time frame
Up to 2 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Princess Marina Hospital Status unavailable Bontleng, GaboroneBotswanaBotswana

Sponsors and contacts

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

University of Alabama at Birmingham

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Harvard School of Public Health (HSPH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: