Study Procedures and Setting/Study Population
In Philadelphia and New York City from 11/2018 to 6/2019, cisgender women were recruited using a variety of strategies, including face-to-face outreach at substance use programs, shelters, street outreach, social media and online postings (Craigslist), and referrals from enrolled women.
The eligibility criteria were based on CDC and New York State PrEP guidelines at the time of the study. Eligibility criteria were: being 18–55 years old; having had condomless vaginal or anal sex with a male partner in the past three months or having injected drugs in the past three months, and reporting at least one of the following: having a current male sex partner who injects drugs, who is HIV seropositive, who has sex with men, or who was incarcerated in the past six months; or reporting their own experiences in the past six months as having: shared injection equipment; used cocaine/crack cocaine, or another stimulant at least 1x/week; been in a medication treatment program for opioid use (methadone, buprenorphine, suboxone); exchanged sex for money, drugs, or services; met the criteria for alcohol dependency (defined as a score of 2 or higher on the CAGE(31)); diagnosed with chlamydia, gonorrhea, syphilis or a new diagnosis of genital herpes; or had 3 or more male sex partners. Women were excluded if they were currently pregnant, currently taking PrEP, planned to relocate out of the area within the next 3 months, did not understand and read English at least 5 grade level, did not have access to a mobile phone, or had a positive rapid HIV test at the first study visit. The study was approved by Institutional Review Boards at [removed for blind review] and had a Certificate of Confidentiality from NIH (CC-MH-16-257). Study visits took place in the research offices in NYC and Philadelphia.
Study Visits
After written informed consent, all participants watched a brief informational video about PrEP for women(32), completed a computer-based baseline questionnaire and received HIV test counseling and an HIV antibody rapid test from a trained HIV counselor/data collector. This was followed by randomization in a 3:1 ratio into the E &A arm or Info arm. Randomization was performed centrally by the project statistician and implemented using opaque sealed envelopes. Envelopes were numbered and shipped to each study site. Balance between arms was maintained by use of randomly permutated blocks with variable 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 was opened, in consecutive order, indicating study arm. Neither the staff nor participants were blinded to study assignment. After randomization, participants then met with the Counselor-Navigator (C-N) who delivered either the E&A or Info arm PrEP intervention. Immediately after the intervention session, participants met again with the data collector to complete the post-intervention computerized questionnaire focused on assessing social-cognitive covariates. At 3-months post enrollment, participants returned for a follow-up visit and completed a follow-up questionnaire on a computer. Participants were provided $50 for each baseline and 3-month visit.
Interventions
Based on the Integrated Behavioral Model(29) and the Theory of Vulnerable Populations(33), the E&A intervention included an in-person, individually-tailored, technology-enhanced, 1-1.5 hour-long information, motivation-enhancement, skill-building, problem-solving, and referral session with follow-up phone calls to support linkage to community-based PrEP care. The E&A intervention consisted of 12 mini-modules facilitated by the C-N and utilized a variety of modalities including video, tablet activities, and physical props. Details about the development, content and pre-piloting of the Just4US-E&A arm are described in a prior publication (author names removed for blind review, 2021). After this initial session, participants received phone calls to support linkage to care and a text-messaging program to promote adherence. Participants in both arms received a packet of handouts on PrEP facts and a list of providers known to prescribe PrEP, along with other materials about, nutrition, smoking cessation, breast cancer screening, etc. The Info arm participants met individually with the C-N who provided a brief description of the handouts in the packet. This session lasted approximately 5–10 minutes. All intervention sessions were audio-recorded.
Training C-ns And Monitoring Quality And Fidelity Of Intervention Sessions
The six C-Ns were experienced staff members and were provided training in content of both intervention arms, goals for each module of the E&A arm, facilitation strategies and provided with a Just4Us E&A and Brief Info intervention manuals. Subsequently, C-Ns had to achieve mastery in session facilitation as determined by two research team members rating video recordings of mock sessions. Ongoing supervision was provided during weekly team meetings. In addition, fidelity and quality were assessed by two study team investigators (AMT & BAK) who listened to the audio recordings of a subset of intervention sessions of both arms and across all C-Ns, using a standardized fidelity rating form. The first three intervention sessions conducted by each C/N were evaluated as well as subsequent sessions intermittently. The form used 5-point Likert response categories (poor to excellent) to assess the following: presentation skills (8 items), e.g. “Conveys ability to engage the participant”; knowledge and communication skills (13 items for E&A arm; 11 items for Info arm), e.g., “Able to deliver intervention in a conversational way (not reading from manual)”; and adherence to module objective(s) depending on the arm (1 item for the Info arm; 12 items pertaining to each module for the E & A arm). There was also an open-ended comments section, in which more specific feedback was provided. C-Ns were given their completed fidelity and quality rating forms as part of ongoing supervision and feedback during the study.
Measures
Baseline measures
Demographic, health and PrEP-relevant sexual and drug behavior data were collected at baseline including age, race/ethnicity, educational level, income, employment, financial instability, recent (past 3 months) injection drug use, condom use with vaginal and anal sex partners, transactional sex and seven relevant factors related to male sexual partners (e.g., had HIV; has sex with other men). Perceived HIV risk was assessed with the question “I believe I am currently at risk of getting HIV” with a 4-point Likert response set which was recoded as a binary outcome for relevant analyses (Disagree Strongly/Disagree vs. Agree/Agree Strongly). Drug use was assessed with 8 questions about any use of specific drugs in the past 3 months, such as heroin, crack cocaine, methamphetamine or other amphetamine, and opiates (such as Oxytocin, Percocet). PrEP awareness was assessed with a question asking participants if they had heard of PrEP prior to participating in this study.
Social-cognitive items, based on the Integrated Behavioral Model (29), were used to assess beliefs about PrEP initiation. We adapted previously developed scales for behavioral, normative and control beliefs regarding their intention to start PrEP in the next 3 months with minor word changes to enhance clarity and additional items for some scales (27). There were five items in the behavioral belief scale, e.g., “Starting PrEP will reduce my chances of getting HIV in the future (alpha = 0.803), four items in the normative belief scale, e.g., “My friends would approve of my starting PrEP” (alpha = 0.836), and nine items in the control belief scale, e.g., “I can talk to my provider if I need PrEP” (alpha = 0.703). All beliefs scales used 4-point Likert agreement response options. Higher scores on these scales indicated positive beliefs about PrEP initiation.
Other relevant social cognitive constructs were included on the questionnaire as we have in prior research(11). We assessed PrEP initiation intention defined as the response to a single 4-point Likert item (1 = Disagree Strongly to 4 = Agree Strongly) using the statement: “I plan to start PrEP in the next 3 months”. We also assessed PrEP adherence intention at baseline, defined as the response to a single 4-point Likert item (Disagree Strongly to Agree Strongly) using the statement: “I plan to take PrEP every day for the next 3 months”. PrEP knowledge was assessed using thirteen questions with true versus false/don’t know response options and an index of correct responses was created for analysis. PrEP stigma was assessed with a slightly modified Women’s PrEP Stigma scale (11) (alpha = 0.861) consisting of six items, e.g. “If I start PrEP, people might gossip about me”, all with a 4-point Likert agree/disagree response set. After adjusting for reverse coding on relevant items, higher values indicated greater anticipated stigma.
Immediate Post-intervention Measures
The post-intervention questionnaire, given to all participants, included social cognitive variables including the behavioral, normative and control beliefs about starting PrEP, PrEP knowledge, and PrEP stigma.
The C-Ns completed online logs after follow-up phone calls for Just4Us E&A participants only, which documented where women were on the PrEP continuum, any challenges or barriers women reported related to accessing PrEP and described an updated action plan based on discussion with the C-Ns.
3-month Follow-up Measures
For all participants, the 3-month questionnaire included all questions asked at baseline (except demographics) with the addition of behavioral outcomes regarding steps on the PrEP continuum, which included: “Did you find a healthcare provider for PrEP?”; “Did you go to your appointment with a healthcare provider to discuss PrEP?”; “Did you get a prescription for PrEP?”; “Did you get a PrEP prescription filled?”; “Did you start taking PrEP?” with a yes/no response option. For each yes response, a follow-up question asked, “How satisfied were you with…..?” with a 4-point Likert response set of “not at all satisfied” to “very satisfied” which was recoded as a binary outcome for relevant analyses. Women who indicated they went to an appointment with a healthcare provider to discuss PrEP but did not receive a prescription, were presented with an open-ended question: “Why did you not get a prescription for PrEP?”. If women started PrEP in past 3 months, they were asked several follow-up questions about where they received their PrEP, duration of PrEP use and their PrEP adherence. At the conclusion of the 3-month survey, participants were asked one exit interview question: “Tell me about your experiences in the past few months as you were thinking about starting PrEP?” Participants were asked an open-ended probe about how they made their decisions about PrEP. In response some women provided specific feedback about their intervention session and how it influenced their PrEP decision-making. Paraphrased responses to the open-ended exit interview were typed in by the data collector.
Data Analysis
Descriptive statistics were used to summarize the participants at baseline on socio-demographic variables, perceived risk and PrEP-relevant behaviors. Cronbach's alphas were generated at baseline for all belief scales. Chi-squared (χ2) tests were used to assess between group (treatment arm) differences in attrition.
At baseline we collected data on 83 participants, with 3 surveys lost due to technical issues with the data capture process, resulting in n = 80 surveys at baseline. At the post intervention session, 1 participant had to leave before completing the survey, resulting in n = 82 post-intervention surveys. At the 3-month follow-up, 8 participants were lost to follow-up resulting in n = 75 surveys at3-month follow-up. We did a complete case analysis and assumed missing data were missing completely at random (MCAR).
Preliminary efficacy of the E&A intervention at 3-month follow-up compared with the Info intervention was tested using unadjusted and adjusted Poisson regression, binomial or linear regression models for count, binary, and continuous outcomes respectively. Unadjusted and adjusted logistic regression models were fitted to assess the effect of the E&A intervention on the PrEP continuum behavioral outcomes at 3-month follow up relative to Info intervention. Generalized estimating equations models with repeated measures were used to test the effect of the E&A intervention on behavioral, normative and control beliefs, stigma and knowledge and intention regarding PrEP initiation, calculated over immediate-post and 3-month follow-up. The intervention's effect on PrEP adherence intention was assessed at 3-month follow up by fitting unadjusted and adjusted regression models. The adjusted regression models included the baseline measure of the respective social cognitive variable, study site and age. All the models were fit with robust standard errors. Analyses were completed using SAS V9.4.
Content analysis of responses to the open-ended and exit interview questions, performed by two team members, was used to classify similar responses. Exit interview data were analyzed 1) to identify barriers, grouped according to the PrEP continuum and 2) feedback linking the intervention to PrEP behaviors or related factors. Any differences between the two team members’ categorizations were resolved through discussion until agreement was reached(34).
Post-intervention audio feedback data regarding quality and fidelity ratings of C-N-delivered intervention sessions were analyzed using descriptive statistics using Excel. In addition, descriptive statistics were used to summarize 3-month follow-up data pertaining to steps on the PrEP continuum for the sample as a whole, HIV prevention behaviors and PrEP intention for those who had not started PrEP and adherence indicators among those who started PrEP. These analyses were completed in SPSS v27 or Excel v18.