HIV/AIDS
Conditions
Brief 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. 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.
Interventions
BEHAVIORALEnhanced Intervention
Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
BEHAVIORALBasic Intervention
General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
Sponsors
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PrEP Uptake and Adherence | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Barriers | Three months, Three month post intervention | 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. |
| Coping Self-Efficacy | Three months, three months post-intervention | 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. |
| PrEP Beliefs | Three month, Three month post intervention | 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. |
| Decisional Conflict | Three months, Three months post intervention | 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. |
| PrEP Benefits | three months, three months post-intervention | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited for the pilot clinical trial from September 2020 to September 2021. Participants were recruited for the formative work that was done prior to developing the intervention on June 1, 2018. All were self-identified females who were clients of Prevention Point Philadelphia, a social services agency and syringe services exchange.
Pre-assignment details
A total of 35 participants were randomized to intervention or control arms. IRB required us to consent women prior to eligibility due to HIPAA. In total, forty nine women were recruited and 48 consented for the study prior to eligibility. Of these, 12 were found to be not eligible based on criteria (i.e. previously used PrEP, no reported HIV risk behavior, no phone). Of the 36 remaining, one was lost before randomization could occur, resulting in a final group of 35 participants.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Intervention 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
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange | 17 |
| Basic Intervention 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
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange | 14 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found out previously on PrEP after randomization before eligibility was expanded | 1 | 1 |
| Overall Study | Lost to Follow-up | 16 | 12 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Enhanced Intervention | Basic Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 17 Participants | 14 Participants |
| Age, Continuous | 40.06 years STANDARD_DEVIATION 9.42 | 40.24 years STANDARD_DEVIATION 10.35 | 39.86 years STANDARD_DEVIATION 8.54 |
| Coping Self-Efficacy | 85.44 units on a scale STANDARD_DEVIATION 17.17 | 83.23 units on a scale STANDARD_DEVIATION 15.85 | 87.83 units on a scale STANDARD_DEVIATION 18.9 |
| Decisional Conflict | 4.32 units on a scale STANDARD_DEVIATION 0.53 | 4.35 units on a scale STANDARD_DEVIATION 0.58 | 4.28 units on a scale STANDARD_DEVIATION 0.48 |
| PrEP Barriers Even if I take PrEP, I might get HIV anyway | 5.13 units on a scale STANDARD_DEVIATION 3.78 | 4.82 units on a scale STANDARD_DEVIATION 4.07 | 5.50 units on a scale STANDARD_DEVIATION 3.53 |
| PrEP Barriers I already protect myself from HIV in other ways (i.e., condoms, not sharing needles) | 3.94 units on a scale STANDARD_DEVIATION 3.67 | 3.65 units on a scale STANDARD_DEVIATION 4 | 4.29 units on a scale STANDARD_DEVIATION 3.34 |
| PrEP Barriers I don't have a safe place to keep PrEP | 1.55 units on a scale STANDARD_DEVIATION 2.15 | 1.71 units on a scale STANDARD_DEVIATION 2.73 | 1.36 units on a scale STANDARD_DEVIATION 2.87 |
| PrEP Barriers I feel healthy so I don't need to take PrEP | 1.52 units on a scale STANDARD_DEVIATION 2.86 | 1.12 units on a scale STANDARD_DEVIATION 2.42 | 2.00 units on a scale STANDARD_DEVIATION 3.35 |
| PrEP Barriers If I started PrEP it would be hard to get to the doctor every three months | 0.84 units on a scale STANDARD_DEVIATION 1.51 | 0.82 units on a scale STANDARD_DEVIATION 1.38 | 0.86 units on a scale STANDARD_DEVIATION 1.7 |
| PrEP Barriers I have a lot more worries in my life than getting HIV | 3.61 units on a scale STANDARD_DEVIATION 3.72 | 3.41 units on a scale STANDARD_DEVIATION 3.97 | 3.86 units on a scale STANDARD_DEVIATION 3.53 |
| PrEP Barriers It would be hard for me to take a pill every day | 1.65 units on a scale STANDARD_DEVIATION 2.86 | 1.41 units on a scale STANDARD_DEVIATION 2.62 | 1.93 units on a scale STANDARD_DEVIATION 3.2 |
| PrEP Barriers I would be afraid if I had PrEP it would get stolen | 1.65 units on a scale STANDARD_DEVIATION 2.44 | 1.59 units on a scale STANDARD_DEVIATION 2.15 | 1.71 units on a scale STANDARD_DEVIATION 2.84 |
| PrEP Barriers My partner might hurt me if they knew I was on PrEP | 0.61 units on a scale STANDARD_DEVIATION 1.54 | 0.41 units on a scale STANDARD_DEVIATION 1.28 | 0.86 units on a scale STANDARD_DEVIATION 1.83 |
| PrEP Barriers PrEP only protects against HIV, not other sexually transmitted infections | 8.81 units on a scale STANDARD_DEVIATION 2.24 | 8.88 units on a scale STANDARD_DEVIATION 2.45 | 8.71 units on a scale STANDARD_DEVIATION 2.05 |
| PrEP Barriers Taking PrEP would cause too many side effects | 1.84 units on a scale STANDARD_DEVIATION 2.28 | 1.41 units on a scale STANDARD_DEVIATION 2.15 | 2.36 units on a scale STANDARD_DEVIATION 2.41 |
| PrEP Barriers Taking PrEP would dull my high | 0.61 units on a scale STANDARD_DEVIATION 1.38 | 0.59 units on a scale STANDARD_DEVIATION 1.33 | 0.64 units on a scale STANDARD_DEVIATION 1.5 |
| PrEP Beliefs Gay men need PrEP more than other people | 3.77 units on a scale STANDARD_DEVIATION 3.66 | 3.88 units on a scale STANDARD_DEVIATION 3.48 | 3.64 units on a scale STANDARD_DEVIATION 3.99 |
| PrEP Beliefs I am more likely to take PrEP if I am being paid to take it | 2.87 units on a scale STANDARD_DEVIATION 3.61 | 2.71 units on a scale STANDARD_DEVIATION 3.65 | 3.07 units on a scale STANDARD_DEVIATION 3.69 |
| PrEP Beliefs People from certain races/ethnicities need PrEP more than other people | 1.55 units on a scale STANDARD_DEVIATION 2.41 | 1.65 units on a scale STANDARD_DEVIATION 2.64 | 1.43 units on a scale STANDARD_DEVIATION 2.17 |
| PrEP Beliefs People who inject drugs need PrEP more than other people | 5.45 units on a scale STANDARD_DEVIATION 4.04 | 6.00 units on a scale STANDARD_DEVIATION 4.11 | 4.79 units on a scale STANDARD_DEVIATION 4 |
| PrEP Beliefs PrEP is safe and effective for women to use | 8.87 units on a scale STANDARD_DEVIATION 2.09 | 9.24 units on a scale STANDARD_DEVIATION 1.35 | 8.43 units on a scale STANDARD_DEVIATION 2.74 |
| PrEP Beliefs PrEP makes people think they are invincible (can't get HIV or other sexually transmitted infections) | 2.52 units on a scale STANDARD_DEVIATION 3.21 | 2.12 units on a scale STANDARD_DEVIATION 2.85 | 3.00 units on a scale STANDARD_DEVIATION 3.66 |
| PrEP Beliefs PrEP sounds too good to be true | 2.17 units on a scale STANDARD_DEVIATION 3.06 | 2.19 units on a scale STANDARD_DEVIATION 3.43 | 2.14 units on a scale STANDARD_DEVIATION 2.71 |
| PrEP Beliefs Sex workers need PrEP more than other people | 4.61 units on a scale STANDARD_DEVIATION 4.08 | 5.29 units on a scale STANDARD_DEVIATION 4.52 | 3.79 units on a scale STANDARD_DEVIATION 3.45 |
| PrEP Beliefs Trans people need PrEP more than other people | 3.48 units on a scale STANDARD_DEVIATION 3.51 | 3.65 units on a scale STANDARD_DEVIATION 3.55 | 3.29 units on a scale STANDARD_DEVIATION 3.58 |
| PrEP Benefits I would be able to enjoy sex more if I was taking PrEP | 6.68 units on a scale STANDARD_DEVIATION 3.33 | 6.88 units on a scale STANDARD_DEVIATION 3.33 | 6.43 units on a scale STANDARD_DEVIATION 3.94 |
| PrEP Benefits I would not have to feel guilty about. having fun if I took PrEP | 5.71 units on a scale STANDARD_DEVIATION 3.81 | 5.41 units on a scale STANDARD_DEVIATION 3.79 | 6.07 units on a scale STANDARD_DEVIATION 3.95 |
| PrEP Benefits I would not have to rely on my partner to use condoms if I was taking PrEP | 2.68 units on a scale STANDARD_DEVIATION 3.3 | 2.12 units on a scale STANDARD_DEVIATION 2.85 | 3.36 units on a scale STANDARD_DEVIATION 3.78 |
| PrEP Benefits I would only have to take one pill a day if I was on PrEP | 9.16 units on a scale STANDARD_DEVIATION 1.7 | 9.18 units on a scale STANDARD_DEVIATION 1.85 | 9.14 units on a scale STANDARD_DEVIATION 1.56 |
| PrEP Benefits PrEP can keep me from getting HIV | 9.06 units on a scale STANDARD_DEVIATION 1.53 | 9.06 units on a scale STANDARD_DEVIATION 1.78 | 9.07 units on a scale STANDARD_DEVIATION 1.21 |
| PrEP Benefits PrEP is affordable | 8.35 units on a scale STANDARD_DEVIATION 2.37 | 8.35 units on a scale STANDARD_DEVIATION 2.74 | 8.36 units on a scale STANDARD_DEVIATION 1.95 |
| PrEP Benefits PrEP is easy to take | 9.58 units on a scale STANDARD_DEVIATION 1.12 | 9.41 units on a scale STANDARD_DEVIATION 1.33 | 9.79 units on a scale STANDARD_DEVIATION 0.8 |
| PrEP Benefits PrEP would let me worry less about HIV | 8.74 units on a scale STANDARD_DEVIATION 2.46 | 9.29 units on a scale STANDARD_DEVIATION 1.36 | 8.07 units on a scale STANDARD_DEVIATION 3.29 |
| PrEP Benefits PrEP would not interfere with me injecting or taking drugs | 8.84 units on a scale STANDARD_DEVIATION 2 | 9.00 units on a scale STANDARD_DEVIATION 1.97 | 8.64 units on a scale STANDARD_DEVIATION 2.1 |
| PrEP Benefits Using PrEP would make me feel more in charge of my life | 8.00 units on a scale STANDARD_DEVIATION 2.66 | 7.71 units on a scale STANDARD_DEVIATION 3.35 | 8.36 units on a scale STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 12 Participants | 8 Participants |
| Region of Enrollment United States | 31 participants | 17 participants | 14 participants |
| Sex: Female, Male Female | 31 Participants | 17 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 14 |
| other Total, other adverse events | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 |
Outcome results
Primary
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.
Time frame: one month, three months, three months post intervention
Population: The enhanced intervention group analysis population at 1 month (n=3) differs from the overall enhanced intervention group n (17), and basic intervention group analysis population at 1 month (n=4) differs from the overall basic intervention group n (14) due to implementation barriers that prevented women from getting onto PrEP (e.g., lack of venous access, not returning for doctor appointment), and remaining adherent (failure to pick up meds, failure to show for appointments).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month | Still taking PrEP, not bio-verified | 0 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 1 month | Still taking PrEP, not bio-verified | 2 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 1 month | Not taking PrEP | 1 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Still taking PrEP, bio-verified | 0 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month | Not taking PrEP | 1 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Still taking PrEP, not bio-verified | 0 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month | Still taking PrEP, bio-verified | 0 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Not taking PrEP | 1 Participants |
| Enhanced Intervention | Change in PrEP Uptake and Adherence | 1 month | Still taking PrEP, bio-verified | 0 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Not taking PrEP | 1 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 1 month | Still taking PrEP, not bio-verified | 3 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 1 month | Not taking PrEP | 0 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month | Still taking PrEP, bio-verified | 1 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month | Still taking PrEP, not bio-verified | 2 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month | Not taking PrEP | 0 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Still taking PrEP, bio-verified | 0 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 3 month follow up | Still taking PrEP, not bio-verified | 0 Participants |
| Basic Intervention | Change in PrEP Uptake and Adherence | 1 month | Still taking PrEP, bio-verified | 1 Participants |
Primary
PrEP Adherence Appraisal
One item Medication Adherence question (one item with 5 option scale). Excellent, Very good, Good, Poor, Very Poor.
Time frame: one month, three months, three months post intervention
Population: Enhanced group at 1month (n=3) differs from the overall enhanced group n (17) \& basic group at 1 month (n=4) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout. No participant at 3 month follow up reported PrEP use.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Poor | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Good | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Very good | 1 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Poor | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Very poor | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Unknown or not reported | 1 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Excellent | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Excellent | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Unknown or not reported | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Very good | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Good | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 1 month | Good | 2 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Poor | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Excellent | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Very poor | 1 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Very poor | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month follow up | Unknown or not reported | 0 Participants |
| Enhanced Intervention | PrEP Adherence Appraisal | 3 month | Very good | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Unknown or not reported | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Very poor | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Excellent | 3 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Very good | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Good | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Poor | 1 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Very poor | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 1 month | Unknown or not reported | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Excellent | 2 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Very good | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Good | 1 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Poor | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month | Unknown or not reported | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Excellent | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Good | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Poor | 0 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Very poor | 1 Participants |
| Basic Intervention | PrEP Adherence Appraisal | 3 month follow up | Very good | 0 Participants |
Primary
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.
Time frame: one month, three months, three months post intervention
Population: Enhanced group at 1month (n=3) differs from the overall enhanced group n (17) \& basic group at 1 month (n=4) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout. No participant at 3 month follow up reported PrEP use.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 5 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 4 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 3 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 2 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 7 days | 1 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 6 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 5 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 4 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 3 days | 1 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 2 days | 1 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 1 day | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | 0 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 1 month | Unknown or not reported | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 7 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 6 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 1 day | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | 0 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month | Unknown or not reported | 1 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 7 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 6 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 5 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 4 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 3 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 2 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 1 day | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | 0 days | 0 Participants |
| Enhanced Intervention | PrEP Adherence Within Past Week | 3 month follow up | Unknown or not reported | 1 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 5 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 5 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 6 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 4 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 2 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 3 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 0 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 1 day | 1 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 7 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 4 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 6 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 0 days | 2 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 5 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 1 day | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 4 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | Unknown or not reported | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 3 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 3 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 2 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 7 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 1 day | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | Unknown or not reported | 1 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | 0 days | 4 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 6 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 1 month | Unknown or not reported | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month follow up | 2 days | 0 Participants |
| Basic Intervention | PrEP Adherence Within Past Week | 3 month | 7 days | 0 Participants |
Secondary
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.
Time frame: Three months, three months post-intervention
Population: Analysis at 3 month and 3 month follow up only includes participants that remained in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Intervention | Coping Self-Efficacy | 3 month | 122 units on a scale | — |
| Enhanced Intervention | Coping Self-Efficacy | 3 month follow up | 130 units on a scale | — |
| Basic Intervention | Coping Self-Efficacy | 3 month | 101 units on a scale | Standard Deviation 28.51 |
| Basic Intervention | Coping Self-Efficacy | 3 month follow up | 84 units on a scale | — |
Secondary
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.
Time frame: Three months, Three months post intervention
Population: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Intervention | Decisional Conflict | 3 month | 5.00 units on a scale | — |
| Enhanced Intervention | Decisional Conflict | 3 month follow up | 5.00 units on a scale | — |
| Basic Intervention | Decisional Conflict | 3 month | 4.64 units on a scale | Standard Deviation 0.56 |
| Basic Intervention | Decisional Conflict | 3 month follow up | 4.85 units on a scale | — |
Secondary
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.
Time frame: Three months, Three month post intervention
Population: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Intervention | PrEP Barriers | 3mofu, It would be hard for me to take a pill every day | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, PrEP only protects against HIV, not other sexually transmitted infections | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, Taking PrEP would dull my high | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, It would be hard for me to take a pill every day | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, Taking PrEP would cause too many side effects | 8.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, My partner might hurt me if they knew I was on PrEP | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, I feel healthy so I don't need to take PrEP | 2.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, I already protect myself from HIV in other ways (condoms, not sharing needles) | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, I already protect myself from HIV in other ways (condoms, not sharing needles) | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, I have a lot more worries in my life than getting HIV | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, Even if I take PrEP, I might get HIV anyway | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, Taking PrEP would dull my high | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, PrEP only protects against HIV, not other sexually transmitted infections | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, If i started PreP it would be hard to get to the doctor every 3 months | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, My partner might hurt me if they knew I was on PrEP | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, Even if I take PrEP, I might get HIV anyway | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, I have a lot more worries in my life than getting HIV | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, I don't have a safe place to keep PrEP | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, If i started PreP it would be hard to get to the doctor every three months | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, I would be afraid if I had PrEP it would get stolen | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, I don't have a safe place to keep PrEP | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, I feel healthy so I don't need to take PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mofu, I would be afraid if I had PrEP it would get stolen | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Barriers | 3mo, Taking PrEP would cause too many side effects | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, I would be afraid if I had PrEP it would get stolen | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mo, I don't have a safe place to keep PrEP | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, It would be hard for me to take a pill every day | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, Taking PrEP would dull my high | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, Taking PrEP would cause too many side effects | 2.00 units on a scale | Standard Deviation 3.46 |
| Basic Intervention | PrEP Barriers | 3mo, I feel healthy so I don't need to take PrEP | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, I already protect myself from HIV in other ways (condoms, not sharing needles) | 5.33 units on a scale | Standard Deviation 3.51 |
| Basic Intervention | PrEP Barriers | 3mo, Even if I take PrEP, I might get HIV anyway | 3.67 units on a scale | Standard Deviation 4.04 |
| Basic Intervention | PrEP Barriers | 3mo, PrEP only protects against HIV, not other sexually transmitted infections | 10.0 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, My partner might hurt me if they knew I was on PrEP | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mo, I have a lot more worries in my life than getting HIV | 9.00 units on a scale | Standard Deviation 1.73 |
| Basic Intervention | PrEP Barriers | 3mo, If i started PreP it would be hard to get to the doctor every 3 months | 0.33 units on a scale | Standard Deviation 0.58 |
| Basic Intervention | PrEP Barriers | 3mo, I would be afraid if I had PrEP it would get stolen | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Barriers | 3mofu, It would be hard for me to take a pill every day | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, Taking PrEP would dull my high | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, Taking PrEP would cause too many side effects | 6.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, I feel healthy so I don't need to take PrEP | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, I already protect myself from HIV in other ways (condoms, not sharing needles) | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, Even if I take PrEP, I might get HIV anyway | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, PrEP only protects against HIV, not other sexually transmitted infections | 10.0 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, My partner might hurt me if they knew I was on PrEP | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, I have a lot more worries in my life than getting HIV | 5.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, If i started PreP it would be hard to get to the doctor every three months | 0.00 units on a scale | — |
| Basic Intervention | PrEP Barriers | 3mofu, I don't have a safe place to keep PrEP | 0.00 units on a scale | — |
Secondary
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.
Time frame: Three month, Three month post intervention
Population: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Intervention | PrEP Beliefs | 3mo, PrEP makes people think they are invincible (can't get HIV or other sexually transmitted infect | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, Sex workers need PrEP more than other people | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, People who inject drugs need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, Gay men need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, Trans people need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, People from certain races/ethnicities need PrEP more than other people | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, PrEP sounds too good to be true | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, PrEP is safe and effective for women to use | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mo, I am more likely to take PrEP if I am being paid to take it | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, Sex workers need PrEP more than other people | 10.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, People who inject drugs need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, Gay men need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, Trans people need PrEP more than other people | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, People from certain races/ethnicities need PrEP more than other people | 10.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, PrEP sounds too good to be true | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, PrEP makes people think they are invincible (can't get HIV or other STIs) | 0.00 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, PrEP is safe and effective for women to use | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Beliefs | 3mofu, I am more likely to take PrEP if I am being paid to take it | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mofu, People from certain races/ethnicities need PrEP more than other people | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, PrEP makes people think they are invincible (can't get HIV or other sexually transmitted infect | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, Sex workers need PrEP more than other people | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, Sex workers need PrEP more than other people | 0.67 units on a scale | Standard Deviation 1.16 |
| Basic Intervention | PrEP Beliefs | 3mofu, I am more likely to take PrEP if I am being paid to take it | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, People who inject drugs need PrEP more than other people | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, People who inject drugs need PrEP more than other people | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, Gay men need PrEP more than other people | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, PrEP sounds too good to be true | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, Trans people need PrEP more than other people | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, Gay men need PrEP more than other people | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, People from certain races/ethnicities need PrEP more than other people | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, PrEP is safe and effective for women to use | 10.0 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, PrEP sounds too good to be true | 0.00 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Beliefs | 3mofu, Trans people need PrEP more than other people | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, PrEP is safe and effective for women to use | 9.67 units on a scale | Standard Deviation 0.58 |
| Basic Intervention | PrEP Beliefs | 3mofu, PrEP makes people think they are invincible (can't get HIV or other STIs) | 0.00 units on a scale | — |
| Basic Intervention | PrEP Beliefs | 3mo, I am more likely to take PrEP if I am being paid to take it | 0.00 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: three months, three months post-intervention
Population: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Intervention | PrEP Benefits | 3mo, PrEP is affordable | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, PrEP would not interfere with me injecting or taking drugs | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, PrEP can keep me from getting HIV | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, PrEP can keep me from getting HIV | 9.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, Using PrEP would make me feel more in charge of my life | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, I would not have to rely on my partner to use condoms if I was taking PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, I would be able to enjoy sex more if I was taking PrEP | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, I would be able to enjoy sex more if I was taking PrEP | 2.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, PreP is easy to take | 5.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, I would only have to take one pill a day if I was on PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, PrEP would not interfere with me injecting or taking drugs | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, I would not have to rely on my partner to use condoms if I was taking PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, I would not have to feel guilty about having fun if I took PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, I would only have to take one pill a day if I Was on PrEP | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, PrEP would let me worry less about HIV | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, PrEP would let me worry less about HIV | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, PrEP is easy to take | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mofu, PrEP is affordable | 10.0 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, I would not have to feel guilty about having fun if I took PrEP | 7.00 units on a scale | — |
| Enhanced Intervention | PrEP Benefits | 3mo, Using PrEP would make me feel more in charge of my life | 9.00 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, PrEP is affordable | 10.0 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mo, PrEP can keep me from getting HIV | 9.67 units on a scale | Standard Deviation 0.58 |
| Basic Intervention | PrEP Benefits | 3mo, Using PrEP would make me feel more in charge of my life | 8.67 units on a scale | Standard Deviation 1.53 |
| Basic Intervention | PrEP Benefits | 3mo, I would be able to enjoy sex more if I was taking PrEP | 8.67 units on a scale | Standard Deviation 1.53 |
| Basic Intervention | PrEP Benefits | 3mo, PrEP is easy to take | 10.0 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Benefits | 3mo, PrEP would not interfere with me injecting or taking drugs | 10.0 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Benefits | 3mo, I would not have to rely on my partner to use condoms if I was taking PrEP | 4.33 units on a scale | Standard Deviation 4.93 |
| Basic Intervention | PrEP Benefits | 3mo, I would only have to take one pill a day if I was on PrEP | 10.0 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Benefits | 3mo, PrEP would let me worry less about HIV | 10.0 units on a scale | Standard Deviation 0 |
| Basic Intervention | PrEP Benefits | 3mo, I would not have to feel guilty about having fun if I took PrEP | 8.00 units on a scale | Standard Deviation 2 |
| Basic Intervention | PrEP Benefits | 3mo, PrEP is affordable | 9.67 units on a scale | Standard Deviation 0.58 |
| Basic Intervention | PrEP Benefits | 3mofu, PrEP can keep me from getting HIV | 5.00 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, Using PrEP would make me feel more in charge of my life | 5.00 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, I would be able to enjoy sex more if I was taking PrEP | 10.00 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, PreP is easy to take | 10.0 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, I would not have to rely on my partner to use condoms if I was taking PrEP | 5.0 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, I would only have to take one pill a day if I Was on PrEP | 10.0 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, I would not have to feel guilty about having fun if I took PrEP | 7.00 units on a scale | — |
| Basic Intervention | PrEP Benefits | 3mofu, PrEP would let me worry less about HIV | 10.0 units on a scale | — |