HIV/AIDSNCT03541642
PrEP Communication Intervention for Female Clients of a Needle Exchange
A study testing Enhanced Intervention and Basic Intervention in people with HIV/AIDS, run by Temple University at 1 site in United States.
Trial summary
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Enhanced Intervention and Basic Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identifying women -HIV-
- 18 or older
- self-report either sharing needles or having unprotected sex in last month
- speak and read English
- Is not currently PrEP
- have cell phone that receives text messages
- have Medicaid/Medicare or other insurance that covers PrEP
Who cannot join
- self-identifying other than female
- HIV+
- under 18 years old
- Doesn't speak/read English
- No HIV risk in last three months
- Are on PrEP
Show all 9Show fewer
- Do not have a cell phone that accepts text messages
- Do not have insurance that covers PrEP
- mental illness that interferes with cognitive understanding or ability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19134
About this study
Official title: Development and Pilot Testing of a PrEP Communication Intervention and Integration Into Existing HIV Testing Services for Female IV Drug Using Clients of a Needle Exchange
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Using perceptual mapping, an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated into messaging in targeted counseling, materials, and text messaging to encourage PrEP adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as improved self-efficacy and lower decisional conflict.
Read the detailed description
Women who inject drugs (WWIDs) are at significantly higher risk of contracting HIV due to both needle sharing and sexual behaviors, yet utilize HIV prevention resources less. Analysis of studies testing pre-exposure prophylaxis (PrEP) has not tested effectiveness in WWIDs and little research exists on their specific barriers to uptake and adherence. The result is a significant group who is highly vulnerable to HIV infection and its negative health consequences, yet is less likely to benefit from PrEP. To address this gap this study will use a rigorous formative evaluation strategy utilizing a unique and innovative marketing evaluation technique. Using perceptual mapping and vector modeling analysis, the investigators will develop 3-D maps to identify specific message strategies to embed into an intervention using targeted PrEP counseling, written materials, and text based messaging and pilot tested for promise of efficacy compared to a general PrEP intervention. The intervention will address psycho-social barriers to PrEP through perceptual mapping but also societal and structural barriers by embedding it in a trusted syringe exchange and distributing medication through its medical clinic. Specific aims of the research are: 1. Assess WWIDs' perceptions of PrEP and potential barriers to use. To accomplish this the investigators will conduct focus groups (n=30) and interviews with syringe exchange staff (n=10) and develop a perceptual mapping survey. 2. Develop a targeted communication intervention based on vector modeling findings, including print materials, PrEP counseling, and text messages, and assess feasibility and acceptability. To accomplish this the investigators will conduct perceptual mapping surveys with HIV- WWIDs (n=100), do vector modeling analysis and create sample messages, concept test messages with WWIDs and staff (n=20), create intervention materials and conduct usability testing (n=20). 3. Pilot test the intervention by integrating into a syringe exchange to assess promise of efficacy. To accomplish this the investigators will conduct a randomized pilot (n=50) and test an "enhanced" intervention using targeted messages with a "basic" intervention that provides general PrEP counseling. To assess promise of efficacy the investigators will compare PrEP adherence (blood test; self report) and differences in PrEP attitudes, self-efficacy, and decisional conflict.
- Conditions
- HIV/AIDS
- Being tested
- Enhanced Intervention, Basic Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced InterventionBehavioural
Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
Basic InterventionBehavioural
General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Intervention | Experimental | Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange Receives: Behavioral: Enhanced Intervention |
| Basic Intervention | Active comparator | Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange Receives: Behavioral: Basic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PrEP Uptake and Adherence
Self-report PrEP adherence and bio-verified PrEP adherence to PrEP with urine assay (Synergy medical labs - Descovy Panel TFV:Creatinine Ratio-Descovy). Urine assay results will be categorized as a binary variable (yes/no) based upon value observed by all patients, with data at 1 month, 3 months and 3 months post intervention.
Measured: one month, three months, three months post intervention
PrEP Adherence Within Past Week
Self report PrEP adherence measure of PrEP use within the past week. Item asks "Of the seven doses of PrEP you were supposed to take during the last week, how many doses would you say you missed? Responses range from 0 to 7.
Measured: one month, three months, three months post intervention
PrEP Adherence Appraisal
One item Medication Adherence question (one item with 5 option scale). "Excellent, Very good, Good, Poor, Very Poor".
Measured: one month, three months, three months post intervention
Secondary outcomes (5)
Coping Self-Efficacy
Assess coping self-efficacy using the Coping Self-Efficacy Scale (13 item scale; 0-10 scale). Zero=cannot do at all,5=moderately certain can do and 10=certain can do. An overall CSE score (from 0 to 130) is created by summing the item ratings, with higher scores indicating higher coping self-efficacy.
Measured: Three months, three months post-intervention
Decisional Conflict
Assess decisional conflict with the Ottawa Decisional Conflict Scale. 13 items. 5 responses: Strongly Disagree (1), Disagree (2), Neither Agree or Disagree (3), Agree (4), Strongly Agree (5). Scores are summed and divided by the number of items(13) to produce an overall mean, ranging from 1 to 5. Lower scores indicate lower decisional conflict.
Measured: Three months, Three months post intervention
PrEP Benefits
10 items assessed perceived benefits of PrEP. Items are asked on a 0-10 Likert, with 0 = strongly agree, 5 = unsure, 10 = strongly agree. Thus, higher scores indicate greater agreement with that item.
Measured: three months, three months post-intervention
PrEP Barriers
12 items assessed perceived barriers to taking PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.
Measured: Three months, Three month post intervention
PrEP Beliefs
9 items assessed perceived beliefs about PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.
Measured: Three month, Three month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jun 2018
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women participants will be randomized to condition upon consent based on a random numbers table. Intervention arm will get "enhanced" intervention with customized messages and counseling/text messaging; control arm will get "basic" intervention with medical counseling and text message reminders.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah B Bass, PhD, MPH, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541642
- Sponsor's protocol ID
- 25028
- Status last verified
- May 2023
- First submitted
- 28 Feb 2018
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research products from the study will be made available to other qualified individuals within the scientific community, government agencies and other interested parties after publication of results. Requests for raw data from other scientists will be considered with provision of the following information: A brief description of the specific aims and/or hypotheses, data requirements, and proposed analyses, how the data will be used, timeframe for use, and Institutional Review Board (IRB) approvals. All materials developed during the study, as well as any research instruments, will also be made available upon request. In addition, qualified individuals who are interested in the PrEP messaging and the methods from which they are created, as well as the analysis methods generated by this research, will have access after publication. It is our full intention to share all findings generated by this study, and subsequent lessons learned, with others in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a PrEP Communication Intervention and Integration Into Existing HIV Testing Services for Female IV Drug Using Clients of a Needle Exchange
- ClinicalTrials.gov ID
- NCT03541642
- Acronym / sponsor ID
- 25028
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Using perceptual mapping, an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated into messaging in targeted counseling, materials, and text messaging to encourage PrEP adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as improved self-efficacy and lower decisional conflict.
Detailed description
Women who inject drugs (WWIDs) are at significantly higher risk of contracting HIV due to both needle sharing and sexual behaviors, yet utilize HIV prevention resources less. Analysis of studies testing pre-exposure prophylaxis (PrEP) has not tested effectiveness in WWIDs and little research exists on their specific barriers to uptake and adherence. The result is a significant group who is highly vulnerable to HIV infection and its negative health consequences, yet is less likely to benefit from PrEP. To address this gap this study will use a rigorous formative evaluation strategy utilizing a unique and innovative marketing evaluation technique. Using perceptual mapping and vector modeling analysis, the investigators will develop 3-D maps to identify specific message strategies to embed into an intervention using targeted PrEP counseling, written materials, and text based messaging and pilot tested for promise of efficacy compared to a general PrEP intervention. The intervention will address psycho-social barriers to PrEP through perceptual mapping but also societal and structural barriers by embedding it in a trusted syringe exchange and distributing medication through its medical clinic. Specific aims of the research are: 1. Assess WWIDs' perceptions of PrEP and potential barriers to use. To accomplish this the investigators will conduct focus groups (n=30) and interviews with syringe exchange staff (n=10) and develop a perceptual mapping survey. 2. Develop a targeted communication intervention based on vector modeling findings, including print materials, PrEP counseling, and text messages, and assess feasibility and acceptability. To accomplish this the investigators will conduct perceptual mapping surveys with HIV- WWIDs (n=100), do vector modeling analysis and create sample messages, concept test messages with WWIDs and staff (n=20), create intervention materials and conduct usability testing (n=20). 3. Pilot test the intervention by integrating into a syringe exchange to assess promise of efficacy. To accomplish this the investigators will conduct a randomized pilot (n=50) and test an "enhanced" intervention using targeted messages with a "basic" intervention that provides general PrEP counseling. To assess promise of efficacy the investigators will compare PrEP adherence (blood test; self report) and differences in PrEP attitudes, self-efficacy, and decisional conflict.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women participants will be randomized to condition upon consent based on a random numbers table. Intervention arm will get "enhanced" intervention with customized messages and counseling/text messaging; control arm will get "basic" intervention with medical counseling and text message reminders.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Intervention | Experimental | Behavioral: Enhanced InterventionWomen who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange |
| Basic Intervention | Active comparator | Behavioral: Basic InterventionWomen who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identifying women -HIV-
- 18 or older
- self-report either sharing needles or having unprotected sex in last month
- speak and read English
- Is not currently PrEP
Key exclusion criteria (9 listed)
- self-identifying other than female
- HIV+
- under 18 years old
- Doesn't speak/read English
- No HIV risk in last three months
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 |
|---|---|---|
| Enhanced InterventionTargeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange | Behavioural | Enhanced Intervention |
| Basic InterventionGeneral messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange | Behavioural | Basic Intervention |
Primary outcome
Change in PrEP Uptake and Adherence
Time frame: one month, three months, three months post intervention
Self-report PrEP adherence and bio-verified PrEP adherence to PrEP with urine assay (Synergy medical labs - Descovy Panel TFV:Creatinine Ratio-Descovy). Urine assay results will be categorized as a binary variable (yes/no) based upon value observed by all patients, with data at 1 month, 3 months and 3 months post intervention.
PrEP Adherence Within Past Week
Time frame: one month, three months, three months post intervention
Self report PrEP adherence measure of PrEP use within the past week. Item asks "Of the seven doses of PrEP you were supposed to take during the last week, how many doses would you say you missed? Responses range from 0 to 7.
PrEP Adherence Appraisal
Time frame: one month, three months, three months post intervention
One item Medication Adherence question (one item with 5 option scale). "Excellent, Very good, Good, Poor, Very Poor".
5 secondary outcomes
Coping Self-Efficacy
Time frame: Three months, three months post-intervention
Decisional Conflict
Time frame: Three months, Three months post intervention
PrEP Benefits
Time frame: three months, three months post-intervention
PrEP Barriers
Time frame: Three months, Three month post intervention
PrEP Beliefs
Time frame: Three month, Three month post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All research products from the study will be made available to other qualified individuals within the scientific community, government agencies and other interested parties after publication of results. Requests for raw data from other scientists will be considered with provision of the following information: A brief description of the specific aims and/or hypotheses, data requirements, and proposed analyses, how the data will be used, timeframe for use, and Institutional Review Board (IRB) approvals. All materials developed during the study, as well as any research instruments, will also be made available upon request. In addition, qualified individuals who are interested in the PrEP messaging and the methods from which they are created, as well as the analysis methods generated by this research, will have access after publication. It is our full intention to share all findings generated by this study, and subsequent lessons learned, with others in the scientific community.
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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.
Sarah B Bass, PhD, MPH principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Intervention and Basic Intervention in people with HIV/AIDS, run by Temple University 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 7 inclusion and 9 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 5 Feb 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in PrEP Uptake and Adherence (time frame: one month, three months, three months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024.