NCT03699722

Brief Summary

Many women at high risk for acquiring HIV infection are not aware of preexposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. The objective of this study is to evaluate the feasibility and acceptability of a theory-based intervention to promote PrEP uptake and adherence in a pilot trial among 80 women. The study will also measure intention to use PrEP and actual initiation of PrEP use. The investigators hypothesize that the intervention will be acceptable and feasible and that the intervention group will report higher levels of PrEP uptake, intention to use and adhere to PrEP, and other variables regarding PrEP uptake, comparing baseline, post-intervention and 3 month follow-up assessments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

November 3, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

September 29, 2018

Last Update Submit

November 12, 2020

Conditions

Behavior and Behavior MechanismsInformation Literacy

Keywords

womenHIVPrEPintervention

Outcome Measures

Primary Outcomes (2)

  • Intervention Fidelity

    Evaluation of fidelity behavior for each module by site coordinator after listening to audio recordings of intervention sessions using a rating form with 90% evaluation items must be 4s or 5s on a 5-point Likert scale.

    baseline session

  • Participant Acceptability of intervention

    At least 80% of participants report moderate or higher levels of acceptability: based on participants' indicating favorable responses indicated by 4s and 5s on a 5 point Likert scale on the Brief Satisfaction Questionnaire

    baseline and 3 months

Secondary Outcomes (1)

  • PrEP uptake behavior

    3 months

Study Arms (2)

Education + Activities

EXPERIMENTAL

12 modules which include the following topics: introduction to the CN and intervention, video about PrEP, PrEP use in combination with other HIV, STI, and pregnancy prevention, identification and strategizing about beliefs regarding PrEP initiation, addressing perceived risk, strategizing about vulnerability factors that may interfere with PrEP uptake, skills building for PrEP uptake, and enhanced referral to a PrEP provider. Up to 4 follow-up phone calls to reinforce strategies. Text messaging for support PrEP adherence.

Behavioral: Education + Activities

Information

ACTIVE COMPARATOR

PrEP information brochures, frequently asked questions and questions to ask provider. Listing of local PrEP providers.

Behavioral: Information

Interventions

Education + ActivitiesBEHAVIORAL

Format:Video; discussion; information handouts; facilitated referral

Education + Activities
InformationBEHAVIORAL

Format: Information handouts

Information

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female at birth and identify as female
  • aged 18-55;
  • report unprotected vaginal or anal sex with a male partner OR any injection drug use in the past 6 months;
  • live or have sex in a high risk area or are recruited into the study by someone who lives or has sex in a high risk area;
  • understand and read English;
  • not known to be HIV-infected;
  • are willing to consider a daily pill with low rates of mild side effects to prevent HIV;
  • have access to a mobile phone.
  • report at least one of the following as 'yes' or 'do not know': current male partner who injects drugs or has sex with men; current male partner who is HIV infected; current male partner who was incarcerated in the last 6 months OR report at least one of the following as 'yes': shared injection equipment in last 6 months; in methadone, buprenorphine or suboxone treatment program in past 6 months; exchange sex for money, drugs, other goods in last 6 months; powder cocaine, crack use, methamphetamines, or ecstasy \>1x/week in last 6 months; Chlamydia, syphilis, gonorrhea diagnosed or newly diagnosed genital herpes in last 6 months; alcohol abuse in last 6 months (defined as a score of 2 or higher on the CAGE36); has 3 or more male partners.

You may not qualify if:

  • currently using PrEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anne Teitelman

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Teitelman AM, Tieu HV, Chittamuru D, Shaw PA, Nandi V, Davis A, Lipsky RK, Darlington CK, Fiore D, Koblin BA. A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women. AIDS Behav. 2023 Sep;27(9):2944-2958. doi: 10.1007/s10461-023-04017-z. Epub 2023 Mar 4.

    PMID: 36869921DERIVED

  • Teitelman AM, Koblin BA, Brawner BM, Davis A, Darlington C, Lipsky RK, Iwu E, Bond KT, Westover J, Fiore D, Tieu HV. Just4Us: Development of a Counselor-Navigator and Text Message Intervention to Promote PrEP Uptake Among Cisgender Women at Elevated Risk for HIV. J Assoc Nurses AIDS Care. 2021 Mar-Apr 01;32(2):188-204. doi: 10.1097/JNC.0000000000000233.

    PMID: 33427767DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Educational StatusExercise

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: At the baseline visit, participants will be randomly assigned to intervention or control conditions in a 3:1 ratio, stratified by site. Participants will remain in those assigned groups for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2018

First Posted

October 9, 2018

Study Start

November 3, 2018

Primary Completion

October 10, 2019

Study Completion

November 10, 2019

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

We are happy to make our research findings readily available for research purposes to qualified individuals within the scientific community through individual requests directed to the Co-Principal Investigators and to share all published findings with the NIH. To protect confidentiality, qualitative data will be release in summary form. Findings from the study will be transmitted both to the scientific community through presentations at conferences and via journal articles and to interested community members through presentations. At each presentation and on each publication, contact information for additional information will be provided.

Locations

US(1)