Behavior and Behavior MechanismsPhase 1Just4UsNCT03699722
A Women-Focused PrEP Intervention
A Phase 1 study testing Education + Activities and Information in people with Behavior and Behavior Mechanisms and Information Literacy, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms, Information Literacy
- What is being tested?
- Education + Activities and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2018to 10 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- currently using PrEP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Women-Focused PrEP Intervention for HIV Prevention
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.
Read the detailed description
The HIV epidemic among women in the US is a major public health issue and many women at high risk for acquiring HIV infection are not aware of pre-exposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. In 2014, the Centers for Disease Control and Prevention (CDC) and the American College of Obstetricians and Gynecologists (ACOG) issued guidelines for evaluating and prescribing PrEP for women at high risk for acquiring HIV. Yet, there are currently no interventions in the US to promote PrEP uptake among high risk women.
The objective of this study is to evaluate an intervention to promote PrEP uptake in two large metropolitan areas with local HIV rates that greatly exceed the national average but with different PrEP public policy and access landscapes. The investigators hypothesize that a theory-based, contextually relevant behavioral intervention combined with linkage to health care and social services, with text message support for adherence, would be feasible and acceptable and would improve PrEP uptake among high risk women.
Eligible women will be recruited primarily via face-to-face recruitment and respondent driven sampling. For respondent driven sampling, enrolled participants will be given three (3) coupons to be given to women in her social network who she thinks would be interested in joining the study. If the person referred attends a baseline visit, the referring participant will receive $10. Assessment of eligibility will be conducted by telephone or in-person. Participant initials and phone number will be recorded on the form. Eligible participants will be scheduled for a study visit at a day and time convenient for her. Study visits will be held at UPenn School of Nursing (Philadelphia) or the New York Blood Center Project Achieve office (NYC) or at a mutually agreeable location in the community that provides a private place for study procedures.
For the randomized trial, the investigators will conduct a study among 80 women to evaluate the feasibility and acceptability of the intervention. Each of the two study sites will enroll forty (40) women; thirty (30) participants will receive the theory-based, contextually tailored education and activities intervention and ten (10) participants will be randomized to the information only control group.
Prior to administering any study procedures women participants will participate in an informed consent process. During the informed consent process research staff will explained some participants will receive the education and activities intervention and some participants will receive information control group. After their questions are answered and participant signs the consent form, all participants will complete a computer-based baseline assessment and receive a rapid HIV test. All participants (control and intervention) will sign a release of information form authorizing the study team to contact the PrEP health care site for the minimal information needed to assess if PrEP was prescribed.
Randomization will be performed centrally by the project statistician, and implemented using opaque sealed envelopes. Envelopes will be numbered and shipped to each study site. Balance between arms will be maintained by use of randomly permutated blocks with unequal block sizes of 4 and 8 (to allow for the 3:1 randomization ratio), and with stratification by site (2 strata). At each site, a sealed envelope will be opened, in consecutive order, indicating study arm.
Upon completing the computer-based survey, participants randomized to the education and activities intervention arm will receive an individual tailored in-person session, conducted by a trained counselor/navigator (CN). Participants will also be asked to design simple personalized text messages for asking about PrEP initiation and PrEP adherence reminders once starting PrEP. Finally, the CN will also coordinate with the participant the best day and time to schedule her four (4) follow-up phone calls. During the phone calls, the CN will reinforce skills for PrEP uptake, review the action plan regarding identified vulnerability factors that could interfere with PrEP uptake and reinforce strategies to access referrals.
Participants randomized to the information only arm will meet with the counselor/navigator to review resources regarding PrEP and receive a list of providers/clinics prescribing PrEP.
After the session, participants will complete a post-session computer-bases survey to assess social-cognitive variables targeted in the intervention. Participants will also complete a Participant's Brief Satisfaction Questionnaire to provide feedback on the session.
All participants will be compensated $50.00 All participants enrolled will return to the study site for a three (3) month follow-up study visit to complete the computer-based survey and a questionnaire evaluating her experience navigating through the process to obtain provider appointment, medical assessment for PreP, prescription and taking PreP. Participants will be compensated $50.00 upon completing the three (3) month follow-up study visit.
- Being tested
- Education + Activities, Information
- Keywords
- women, HIV, PrEP, intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education + ActivitiesBehavioural
Format:Video; discussion; information handouts; facilitated referral
InformationBehavioural
Format: Information handouts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education + Activities |
| Information | Active comparator | PrEP information brochures, frequently asked questions and questions to ask provider. Listing of local PrEP providers. Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline and 3 months
Secondary outcomes (1)
PrEP uptake behavior
PrEP uptake behavior (Preliminary Impact) as reported by self report at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start3 Nov 2018
- Primary completion10 Oct 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center
- Responsible party
- Principal investigator, Anne Teitelman, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699722
- Sponsor's protocol ID
- 1R34MH108437-01A1
- Acronym
- Just4Us
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36869921Teitelman 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.
PubMed 33427767
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Women-Focused PrEP Intervention for HIV Prevention
- ClinicalTrials.gov ID
- NCT03699722
- Acronym / sponsor ID
- Just4Us / 1R34MH108437-01A1
- Keywords
- women, HIV, PrEP, intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- New York Blood Center
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HIV epidemic among women in the US is a major public health issue and many women at high risk for acquiring HIV infection are not aware of pre-exposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. In 2014, the Centers for Disease Control and Prevention (CDC) and the American College of Obstetricians and Gynecologists (ACOG) issued guidelines for evaluating and prescribing PrEP for women at high risk for acquiring HIV. Yet, there are currently no interventions in the US to promote PrEP uptake among high risk women.
The objective of this study is to evaluate an intervention to promote PrEP uptake in two large metropolitan areas with local HIV rates that greatly exceed the national average but with different PrEP public policy and access landscapes. The investigators hypothesize that a theory-based, contextually relevant behavioral intervention combined with linkage to health care and social services, with text message support for adherence, would be feasible and acceptable and would improve PrEP uptake among high risk women.
Eligible women will be recruited primarily via face-to-face recruitment and respondent driven sampling. For respondent driven sampling, enrolled participants will be given three (3) coupons to be given to women in her social network who she thinks would be interested in joining the study. If the person referred attends a baseline visit, the referring participant will receive $10. Assessment of eligibility will be conducted by telephone or in-person. Participant initials and phone number will be recorded on the form. Eligible participants will be scheduled for a study visit at a day and time convenient for her. Study visits will be held at UPenn School of Nursing (Philadelphia) or the New York Blood Center Project Achieve office (NYC) or at a mutually agreeable location in the community that provides a private place for study procedures.
For the randomized trial, the investigators will conduct a study among 80 women to evaluate the feasibility and acceptability of the intervention. Each of the two study sites will enroll forty (40) women; thirty (30) participants will receive the theory-based, contextually tailored education and activities intervention and ten (10) participants will be randomized to the information only control group.
Prior to administering any study procedures women participants will participate in an informed consent process. During the informed consent process research staff will explained some participants will receive the education and activities intervention and some participants will receive information control group. After their questions are answered and participant signs the consent form, all participants will complete a computer-based baseline assessment and receive a rapid HIV test. All participants (control and intervention) will sign a release of information form authorizing the study team to contact the PrEP health care site for the minimal information needed to assess if PrEP was prescribed.
Randomization will be performed centrally by the project statistician, and implemented using opaque sealed envelopes. Envelopes will be numbered and shipped to each study site. Balance between arms will be maintained by use of randomly permutated blocks with unequal block sizes of 4 and 8 (to allow for the 3:1 randomization ratio), and with stratification by site (2 strata). At each site, a sealed envelope will be opened, in consecutive order, indicating study arm.
Upon completing the computer-based survey, participants randomized to the education and activities intervention arm will receive an individual tailored in-person session, conducted by a trained counselor/navigator (CN). Participants will also be asked to design simple personalized text messages for asking about PrEP initiation and PrEP adherence reminders once starting PrEP. Finally, the CN will also coordinate with the participant the best day and time to schedule her four (4) follow-up phone calls. During the phone calls, the CN will reinforce skills for PrEP uptake, review the action plan regarding identified vulnerability factors that could interfere with PrEP uptake and reinforce strategies to access referrals.
Participants randomized to the information only arm will meet with the counselor/navigator to review resources regarding PrEP and receive a list of providers/clinics prescribing PrEP.
After the session, participants will complete a post-session computer-bases survey to assess social-cognitive variables targeted in the intervention. Participants will also complete a Participant's Brief Satisfaction Questionnaire to provide feedback on the session.
All participants will be compensated $50.00 All participants enrolled will return to the study site for a three (3) month follow-up study visit to complete the computer-based survey and a questionnaire evaluating her experience navigating through the process to obtain provider appointment, medical assessment for PreP, prescription and taking PreP. Participants will be compensated $50.00 upon completing the three (3) month follow-up study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Education + Activities | Experimental | Behavioral: Education + Activities12 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. |
| Information | Active comparator | Behavioral: InformationPrEP information brochures, frequently asked questions and questions to ask provider. Listing of local PrEP providers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (1 listed)
- currently using PrEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education + ActivitiesFormat:Video; discussion; information handouts; facilitated referral | Behavioural | Education + Activities |
| InformationFormat: Information handouts | Behavioural | Information |
Primary outcome
Intervention Fidelity
Time frame: baseline session
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.
Participant Acceptability of intervention
Time frame: baseline and 3 months
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
1 secondary outcome
PrEP uptake behavior
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 36869921Teitelman 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.
- Derived from this study: PubMed 33427767Teitelman 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Education + Activities and Information in people with Behavior and Behavior Mechanisms and Information Literacy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Fidelity (time frame: baseline session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.