An interventional study of NIDA Standard for HIV Prevention in HIV/AIDS, sponsored by Michele Staton. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Michele Staton · Not applicable, Interventional, and Prevention
Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 641st largest by enrollment of the 1,290 interventional ones, is one of 77 that started in 2019, is one of 642 with no phase, and was the 1,238th registered.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 60 is below the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 197 Acquired Immunodeficiency Syndrome studies recruiting now, 117 (59%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →1,670 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 77 started in 2019.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
510 of 1,670 have an industry lead sponsor. The 10 most frequent:
Michele Staton is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Michele Staton has 2 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
58 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase access to prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors among vulnerable populations.
The overall aim of this R34 application is to adapt and feasibility test an evidence-based intervention for HIV prevention for a high-risk group of rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase the reach and scope of prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors of this underserved group. Considering the need for prevention interventions among this high-risk group and the popularity of Facebook, the purpose of this R34 proposal is to adapt an evidence-based HIV prevention intervention for social media delivery and to feasibility test through a randomized control trial with 60 high-risk rural women drug users. The following aims guide the proposed study: (1) Adapt the NIDA Standard for HIV prevention for delivery via Facebook; and (2) Examine the feasibility of the adapted intervention with high-risk rural women through a randomized control pilot. The proposed use of Facebook in this study is promising because it is a stable, widely used, cost-efficient platform that could be leveraged to increase access to critically needed HIV prevention education. This study presents an exciting opportunity to examine the use of Facebook as a technique to expand the reach of evidence-based preventions interventions for high-risk drug users who are not likely to engage in formal treatment. Findings from this study will inform development of the larger R01 which would allow examination of the effectiveness and sustainability of this HIV prevention intervention in understudied, high risk populations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the NIDA Standard via Facebook
Behavioral: NIDA Standard for HIV Prevention
Participants will receive standard re-entry services available in the community and through the criminal justice system
The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial.
Facebook Enrollment
The number of participants who are released and accept the "friend" request from the Facebook study profile
Time frame: 3 months
Number of Participants With Use of Injected Drugs
Use of injected drugs in the last 3-months at follow-up
Time frame: 3 months
| Milestone | NIDA Standard Via Facebook | Re-entry Services as Usual |
|---|---|---|
| Started | 30 | 30 |
| Completed | 27 | 23 |
| Not completed | 3 | 7 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Not released to community | 1 | 5 |
| Withdrew: Lost to follow-up | 0 | 2 |
The number of participants who are released and accept the "friend" request from the Facebook study profile
| Participants | NIDA Standard Via Facebook | Re-entry Services as Usual |
|---|---|---|
| Facebook Enrollment | 15 | 15 |
Use of injected drugs in the last 3-months at follow-up
| Participants | NIDA Standard Via Facebook | Re-entry Services as Usual |
|---|---|---|
| Number of Participants With Use of Injected Drugs | 8 | 6 |
Collected over 3 months after Baseline completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NIDA Standard Via Facebook | 0/27 (0%) | 2/27 (7.4%) | 20/27 (74.1%) |
| Re-entry Services as Usual | 0/23 (0%) | 0/23 (0%) | 19/23 (82.6%) |
| Event | NIDA Standard Via Facebook | Re-entry Services as Usual |
|---|---|---|
| Non-fatal overdoseGeneral disorders | 2/27 | 0/23 |
| Event | NIDA Standard Via Facebook | Re-entry Services as Usual |
|---|---|---|
| Any health problemsGeneral disorders | 10/27 | 11/23 |
| Any mental health problemsPsychiatric disorders | 9/27 | 9/23 |
| ReincarceratedSocial circumstances | 8/27 | 7/23 |
| Age, Continuous(years) | NIDA Standard Via Facebook | Re-entry Services as Usual | Total |
|---|---|---|---|
| Mean | 34.6 ± 8.6 | 38.3 ± 7.3 | 36.4 ± 8.1 |
| Sex: Female, Male(Participants) | NIDA Standard Via Facebook | Re-entry Services as Usual | Total |
|---|---|---|---|
| Female | 30 | 30 | 60 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NIDA Standard Via Facebook | Re-entry Services as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 30 | 30 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Number of Years of Education Completed(years) | NIDA Standard Via Facebook | Re-entry Services as Usual | Total |
|---|---|---|---|
| Mean | 11.6 ± 2.0 | 12.7 ± 1.9 | 12.1 ± 2.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Apr 2022, 34 months.
Results were first posted in May 2023, 1 year after primary completion.
Of 641 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 34 months is above that.
Counting every sponsor, half of 647 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Michele Staton