Counselor-Led Just4Us Program Shows Strong Feasibility for Boosting PrEP Uptake Among Women

Pre-exposure prophylaxis, or PrEP, has transformed HIV prevention since its approval, reducing the risk of acquiring HIV through sex by roughly 99 percent when taken as prescribed. Yet in the United States, one group has been largely left out of that success story: women. Women account for about 19 percent of new HIV infections in the country, but only a small fraction of PrEP users are women, and many women—particularly women of color—have never even heard of the medication as a prevention option. A new pilot randomized controlled trial published in the Archives of Sexual Behavior suggests that a carefully designed, woman-focused intervention called Just4Us may help close that gap, demonstrating both strong feasibility and high acceptability among the women it was built to serve.

The study, led by Hong-Van Tieu of the New York Blood Center and Columbia University Irving Medical Center together with Beryl Koblin, Anne M. Teitelman, and colleagues in New York City and Philadelphia, enrolled 83 cisgender women aged 18 to 55 who were not living with HIV, were not currently taking PrEP, and met established clinical eligibility guidelines for the medication. The participants were randomized in a 3:1 ratio, with 61 women assigned to the full Just4Us Education and Activities arm and 22 women assigned to an Information-only comparison arm. Both groups received PrEP information and a referral list of local providers, but the intervention arm received a far more intensive, personalized package of support designed to move women from awareness to actual initiation and sustained use of PrEP.

The Just4Us intervention is grounded in behavioral theory and shaped directly by formative research with women at elevated risk for HIV. At its core is an individually delivered session with a counselor-navigator—a trained professional who combines the roles of health educator and care coordinator. During the session, the counselor-navigator provides detailed information about PrEP, works through motivation enhancement exercises, builds practical skills for negotiating prevention with partners and navigating the health care system, engages in collaborative problem-solving around barriers such as cost, transportation, and stigma, and makes concrete referrals to PrEP-prescribing clinics. The session incorporates tablet-based activities and a video, giving participants interactive ways to engage with the material rather than passively receiving it.

What distinguishes Just4Us from many one-off counseling interventions is the support that continues after the initial session. Between baseline and the three-month follow-up, women in the intervention arm received telephone calls from their counselor-navigator to support linkage to PrEP care, along with text messages designed to promote adherence for those who started the medication. This two-pronged follow-up strategy reflects a growing recognition in implementation science that the moment a woman decides to try PrEP is often the moment she encounters the greatest logistical obstacles—insurance paperwork, clinic wait times, lab appointments—and that sustained, low-burden contact can keep her moving forward.

The feasibility results were striking. The attendance rate for the initial session was 100 percent in both arms, meaning every single enrolled woman showed up for her assigned intervention. Retention at three months was 90 percent, an exceptionally high figure for a population of socially disadvantaged women who often face competing demands on their time and unstable access to health care. The research team also exceeded its diversity and enrollment targets: 79 percent of participants were Black and 26 percent were Latina, ensuring that the intervention was tested among the very communities that bear a disproportionate share of new HIV infections among women in the United States.

Acceptability data were equally encouraging. Among women in the intervention arm, 95 percent reported feeling very satisfied or satisfied with the overall session, and 97 percent expressed satisfaction with their discussion with the counselor-navigator. The tablet activities earned a 95 percent satisfaction rating, the text-messaging setup 93 percent, and the video 90 percent. Across both arms, 78 percent of participants felt the session length was just right, and an overwhelming 95 percent said they would recommend or strongly recommend Just4Us to others. These numbers matter because acceptability is often the Achilles’ heel of behavioral interventions: a program can be clinically effective on paper but fail in the real world if participants find it burdensome, judgmental, or irrelevant to their lives.

The success of Just4Us is best understood against the backdrop of persistent barriers that keep women away from PrEP. Previous work by the same research team, including a theory-informed elicitation study published in AIDS Care, identified individual, social, and structural factors that shape PrEP uptake among cisgender women, including limited awareness, concerns about side effects, mistrust of the medical system, and the dual burdens of PrEP stigma and HIV stigma. Research published in Stigma and Health by the team found that both PrEP-specific and HIV-related stigma were associated with lower intention to use PrEP among women in New York City and Philadelphia. A woman may worry that seeking PrEP will lead others to assume she is HIV-positive or sexually promiscuous, a concern that has no direct parallel in many other prevention contexts and that demands an intervention tailored specifically to women’s social realities.

The trial also arrives at a moment of rapid expansion in biomedical HIV prevention options. In 2024, the U.S. Food and Drug Administration approved the first injectable treatment for HIV pre-exposure prevention, and the PURPOSE 1 trial reported in the New England Journal of Medicine that twice-yearly lenacapavir provided striking protection for cisgender women. The HPTN 084 trial had already demonstrated the efficacy of long-acting cabotegravir in women, and the DELIVER study established the safety of the dapivirine vaginal ring and oral PrEP during pregnancy. Yet these advances only translate into public health impact if women at risk actually access the tools, which makes behavioral interventions like Just4Us—the connective tissue between biomedical products and the people who need them—more important than ever. The Centers for Disease Control and Prevention has emphasized expanding PrEP coverage as a cornerstone of the Ending the HIV Epidemic initiative, and implementation research on pharmacist-led services, nurse-led clinics, and integration into obstetrics and gynecology settings all points to the same conclusion: delivery models must meet women where they are.

The Just4Us study team was able to recruit the target number of PrEP-eligible women, implement the interventions with a high degree of fidelity, and retain participants through follow-up, all of which are essential prerequisites for a larger efficacy trial. The pilot’s design, funded by the National Institute of Mental Health through an intervention development grant, reflects a deliberate staged approach: first demonstrate that the intervention can be delivered as intended and embraced by participants, then test whether it actually increases PrEP initiation and adherence compared with standard information provision. The high satisfaction ratings and near-perfect attendance suggest that the counselor-navigator model, the interactive tablet activities, and the text-message support struck a chord with women who have historically been underserved by HIV prevention systems.

Limitations remain, as they do in any pilot study. The trial was small, conducted in two East Coast cities, and not powered to detect differences in PrEP uptake between arms; the 3:1 randomization prioritized refining the intervention over hypothesis testing. The published report does not provide outcome data on how many women in each arm ultimately initiated PrEP, which will be the critical question for future efficacy research. Still, the findings offer a concrete template for what woman-centered PrEP support can look like: a trusted navigator, culturally attuned content, flexible digital tools, and sustained follow-up that treats linkage to care and adherence as ongoing processes rather than single events. As longer-acting prevention options broaden the menu of choices, interventions like Just4Us will be essential to ensure that women—especially Black and Latina women, who have borne the heaviest burden of a prevention gap—are not left behind in the next chapter of the HIV epidemic.

Subject of Research: A woman-focused behavioral intervention to promote PrEP uptake and adherence among cisgender women at risk for HIV

Article Title: Just4Us: Acceptability and Feasibility of a Woman-Focused Pre-exposure Prophylaxis (PrEP) Randomized Controlled Trial Intervention

Article References: Tieu, H.-V., Koblin, B., Nandi, V., Davis, A., Phan, A., Fiore, D., Teitelman, A. M., & The Just4Us Study Team (2026). Just4Us: Acceptability and Feasibility of a Woman-Focused Pre-exposure Prophylaxis (PrEP) Randomized Controlled Trial Intervention. Archives of Sexual Behavior. https://doi.org/10.1007/s10508-026-03524-z

Image Credits: AI Generated

DOI: 10.1007/s10508-026-03524-z

Keywords: HIV prevention, pre-exposure prophylaxis, PrEP, women's health, randomized controlled trial, counselor-navigator, health disparities, behavioral intervention, Black women, Latina women, text messaging, HIV stigma