Video-logs for HIV Prevention
(PrEP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMandy Hill, DrPH,MPH,HIVPCP
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: The University of Texas Medical Branch, Galveston
Must be taking: PrEP
Disqualifiers: Severe cognitive impairment, Psychological distress, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston/Harris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing willingness to start PrEP among participants.
What data supports the effectiveness of the Video-log (vlog) series treatment for HIV prevention?
Research shows that video-based interventions, like smartphone-delivered videos, are acceptable and engaging for people in HIV prevention programs. Additionally, technology-based interventions, such as videophone sessions, have been effective in improving medication adherence in people living with HIV.
12345Is there any safety data available for the Video-log series used in HIV prevention trials?
The research articles provided do not contain specific safety data for the Video-log series or similar interventions in HIV prevention trials.
678910How does the Video-logs for HIV Prevention treatment differ from other HIV prevention methods?
The Video-logs for HIV Prevention treatment is unique because it uses video-based interventions delivered via smartphones or handheld devices to educate and reduce HIV risk, making it accessible and engaging for users. This approach leverages technology to provide real-time, personalized education, which is different from traditional methods that may not utilize digital platforms.
15111213Eligibility Criteria
This trial is for cisgender Black women in Houston/Harris County interested in HIV prevention, and healthcare providers willing to prescribe/refer PrEP. Specific eligibility criteria are not detailed here.Inclusion Criteria
I was assigned female at birth.
Participants in the category for CBW must be PrEP-eligible according to CDC criteria
Participants in the category for CBW must be fluent in English
+3 more
Exclusion Criteria
Participants (i.e., PrEP-eligible CBW) must not be ineligible for PrEP
Participants (i.e., PrEP-eligible CBW) must not be unable or unwilling to meet study requirements
Participants (i.e., PrEP-eligible CBW) must not be unable to provide informed consent/assent for participation (i.e., have severe cognitive impairment that would interfere with their ability to consent or understand study procedures)
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants will watch a health-informed video-log series and complete a second survey (post-test)
6 months
Baseline, 1-month, 3-month, and 6-month visits
Follow-up
Participants are monitored for willingness to access/use PrEP and adherence to PrEP regimen
6 months
1-month, 3-month, and 6-month follow-up visits
Participant Groups
The study tests whether video logs (vlogs) tailored to either the women or their healthcare providers can increase willingness and actual initiation of PrEP for HIV prevention.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will watch a health-informed video-log series and complete a second survey (post-test). The post-test will assess the same variables previously assessed in the pre-test.
Group II: Standard of CareActive Control1 Intervention
Participant will receive SOC and complete the post-test.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Medical Branch, GalvestonGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Smartphone Delivery of Mobile HIV Risk Reduction Education. [2022]We sought to develop and deploy a video-based smartphone-delivered mobile HIV Risk Reduction (mHIVRR) intervention to individuals in an addiction treatment clinic. We developed 3 video modules that consisted of a 10-minute HIVRR video, 11 acceptability questions, and 3 knowledge questions and deployed them as a secondary study within a larger study of ecological momentary and geographical momentary assessments. All 24 individuals who remained in the main study long enough completed the mHIVRR secondary study. All 3 videos met our a priori criteria for acceptability "as is" in the population: they achieved median scores of ≤2.5 on a 5-point Likert scale; ≤20% of the individuals gave them the most negative rating on the scale; a majority of the individuals stated that they would not prefer other formats over video-based smartphone-delivered one (all P
A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. [2022]eHealth, mHealth and "Web 2.0" social media strategies can effectively reach and engage key populations in HIV prevention across the testing, treatment, and care continuum. To assess how these tools are currently being used within the field of HIV prevention and care, we systematically reviewed recent (2013-2014) published literature, conference abstracts, and funded research. Our searches identified 23 published intervention studies and 32 funded projects underway. In this synthesis we describe the technology modes applied and the stages of the HIV care cascade addressed, including both primary and secondary prevention activities. Overall trends include use of new tools including social networking sites, provision of real-time assessment and feedback, gamification and virtual reality. While there has been increasing attention to use of technology to address the care continuum, gaps remain around linkage to care, retention in care, and initiation of antiretroviral therapy.
A Fluctuating Pattern of Over- and Under-Adherence for HAART: A Case Study from a Videophone Intervention Project. [2021]Highly Active Antiretroviral Therapy (HAART) has transformed HIV from a terminal illness to a chronic condition. While disagreement remains regarding the level of medication adherence required to achieve and maintain viral suppression, the highest possible rate is preferable. This article discusses the case study of "Bob," a 54 year-old man living with HIV for 25 years. At baseline, Bob evinced fluctuating patterns of medication over- and under-adherence and reported numerous negative side effects. Bob participated in eight videophone-administered adherence intervention sessions. His adherence improved to a high of 97.9% at one-month follow-up; his negative treatment side effects subsided considerably. This case study demonstrates that videophone technology is a potential medium by which to assess and intervene upon HIV medication adherence.
The Feasibility and Acceptability of Using Technology-Based Daily Diaries with HIV-Infected Young Men Who have Sex with Men: A Comparison of Internet and Voice Modalities. [2018]This study delivered a daily diary to 67 HIV-infected men who have sex with men (MSM) between 16 and 24 years old for 66 days to measure HIV-risk behaviors and other psychosocial variables via two diary modalities: internet (accessible via any web-enabled device) and voice (accessible via telephone). Participants were randomized to complete one diary modality for 33 days before switching to the second modality for 33 days. The study was implemented in three urban HIV health care centers in the United States where participants were receiving services. Through diary data and qualitative interview data, we examined the feasibility and acceptability of the dairies and identified barriers and facilitators of dairy compliance. Results show high participant retention in the daily diary (93.4 %) and high compliance for the number of dairies completed (72.4 %). Internet diaries were preferred by 92 % of participants and completed at a significantly higher rate (77.5 %) than voice diaries (67.7 %). Facilitators included opportunities for self-reflection and cathartic sharing, monetary compensation, relationships with study staff, and daily reminders. Barriers included being busy or not having privacy at the time of reminders, forgetting, and falling asleep. Participants also described barriers and facilitators unique to each modality. Overall, both modalities were feasible and acceptable for use with our sample of HIV-infected MSM.
A daily web diary of the sexual experiences of men who have sex with men: comparisons with a retrospective recall survey. [2022]The emergence of Internet technology provides a unique opportunity to collect real-time information on the sexual behaviors of persons at risk for HIV. However, relatively little is known of the utility and reliability of web diaries. To address this gap, 45 predominantly Caucasian and gay, Internet-using men who have sex with men completed a 4-week daily web diary of their sexual behaviors. Afterward, participants completed an online retrospective recall survey (RRS) of their sexual activities during the diary period and satisfaction ratings of the web diary method. Overall, web diary estimates of sexual behaviors differed from the RRS, with a tendency to over-report on the latter with the exception of insertive unprotected anal intercourse. Additionally, compliance rates were high and there was some evidence for reactivity. Participants evaluated the web diary method positively. Web diaries appear to be a promising tool for collecting information on health behaviors.
Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. [2019]Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials.
Designing & Conducting Trials To Reliably Evaluate HIV Prevention Interventions. [2022]While much has been achieved, much remains to be accomplished in the science of preventing the spread of HIV infection. Clinical trials that are properly designed, conducted and analyzed are of integral importance in the pursuit of reliable insights about HIV prevention. As we build on previous scientific breakthroughs, there will be an increasing need for clinical trials to be designed to efficiently achieve insights without compromising their reliability and generalizability. Key design features should continue to include: 1) the use of randomization and evidence-based controls, 2) specifying the use of intention-to-treat analyses to preserve the integrity of randomization and to increase interpretability of results, 3) obtaining direct assessments of effects on clinical endpoints such as the risk of HIV infection, 4) using either superiority designs or non-inferiority designs with rigorous non-inferiority margins, and 5) enhancing generalizability through the choice of a relative risk rather than risk difference metric. When interventions have complementary and potentially synergistic effects, factorial designs should be considered to increase efficiency as well as to obtain clinically important insights about interaction and the contribution of component interventions to the efficacy and safety of combination regimens. Key trial conduct issues include timely enrollment of participants at high HIV risk recruited from populations with high viral burden, obtaining 'best real-world achievable' levels of adherence to the interventions being assessed and ensuring high levels of retention. High quality of trial conduct occurs through active rather than passive monitoring, using pre-specified targeted levels of performance with defined methods to achieve those targets. During trial conduct, active monitoring of the performance standards not only holds the trial leaders accountable but also can assist in the development and implementation of creative alternative approaches to increase the quality of trial conduct. Designing, conducting and analyzing HIV prevention trials with the quality needed to obtain reliable insights is an ethical as well as scientific imperative.
Designing HIV Vaccine Efficacy Trials in the Context of Highly Effective Non-vaccine Prevention Modalities. [2023]The evolving HIV prevention landscape poses challenges to the statistical design of future trials of candidate HIV vaccines. Study designs must address the anticipated reduction in HIV incidence due to adding new prevention modalities to the standard prevention package provided to trial participants, and must also accommodate individual choices of participants with regard to the use of these modalities. We explore four potential trial designs that address these challenges, with a focus on accommodating the newest addition to the prevention package-antiretroviral-based oral pre-exposure prophylaxis (PrEP). The designs differ with respect to how individuals who take up oral PrEP at screening are handled. An All-Comers Design enrolls and randomizes all eligible individuals, a Decliners Design enrolls and randomizes only those who decline PrEP at screening, and Single and Multi-Stage Run-In Designs enroll all but randomize only those who decline PrEP or show inadequate adherence to PrEP after one or multiple run-in periods. We compare these designs with respect to required sample sizes, study duration, and resource requirements, using a simulation model that incorporates data on HIV risk and PrEP uptake and adherence among men who have sex with men (MSM) in the Americas. We advocate considering Run-In Designs for some future contexts, and identify their advantages and tradeoffs relative to the other designs. The design concepts apply beyond HIV vaccines to other prevention modalities being developed with the aim to achieve further reductions in HIV incidence.
Recruitment of urban US women at risk for HIV infection and willingness to participate in future HIV vaccine trials. [2021]Enrollment of US women with sufficient risk of HIV infection into HIV vaccine efficacy trials has proved challenging. A cohort of 799 HIV-negative women, aged 18-45, recruited from three US cities was enrolled to assess recruitment strategies based on geographic risk pockets, social and sexual networks and occurrence of sexual concurrency and to assess HIV seroincidence during follow-up (to be reported later). Among enrolled women, 90 % lived or engaged in risk behaviors within a local risk pocket, 64 % had a male partner who had concurrent partners and 50 % had a male partner who had been recently incarcerated. Nearly half (46 %) were recruited through peer referral. At enrollment, 86 % of women said they were willing to participate in a vaccine efficacy trial. Results indicate that participant and partner risk behaviors combined with a peer referral recruitment strategy may best identify an at-risk cohort willing to participate in future trials.
Minimum dataset for monitoring national human immunodeficiency virus pre-exposure prophylaxis (HIV PrEP) programmes: a five-nation consensus, 2019. [2022]Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), the use of antiretroviral medication to prevent HIV acquisition, is a highly effective biomedical prevention tool. The World Health Organization (WHO) recommends PrEP for people at substantial risk of HIV infection, as part of combination prevention, and highlights the need for robust evaluation of PrEP programmes. Based on suggested WHO core indicators, we created a concise set of HIV PrEP-related dataset variables, to harmonise the monitoring and evaluation of PrEP programmes across five closely related nations (England, Northern Ireland, Ireland, Scotland and Wales). The dataset is based on the PrEP cascade and is intended to represent the minimum variables needed for reporting and comparison of meaningful data at national and multinational level. The dataset can be modified for settings with different health and surveillance systems. It is intended for public health, academic, clinical and health planning, and public audiences. Here we describe the dataset and illustrate its use with data from the first year of the Scottish National PrEP programme.
Educational technologies and practices for prevention of vertical HIV transmission. [2019]to assess available evidence on educational technologies and practices for prevention of vertical HIV transmission.
Soap opera video on handheld computers to reduce young urban women's HIV sex risk. [2022]The purpose of this study was to develop a soap opera video, A Story about Toni, Mike, and Valerie, designed to communicate HIV risk reduction themes. The study evaluated viewing the video and responding to audio computer assisted self-interview (ACASI) on a handheld computer. The sample was 76 predominately African American women, aged 18-29, in sexual relationships with men. Data were collected in urban neighborhoods in the northeastern United States. A pretest-posttest control group design with systematic assignment indicated statistically significant reduction in expectations to engage in unprotected sex in the experimental group. The handheld computer was found to be acceptable to view the near feature length video and complete ACASI. To date, no study has reported on use of video and ACASI on a handheld device to reduce HIV risk. The significance is the potential to stream health promotion videos to personal devices, such as cell phones.
"Is Your Man Stepping Out?" An Online Pilot Study to Evaluate Acceptability of a Guide-Enhanced HIV Prevention Soap Opera Video Series and Feasibility of Recruitment by Facebook Advertising. [2022]Love, Sex, and Choices (LSC) is a 12-episode soap opera video series developed to reduce HIV risk among at-risk Black urban women. We added a video guide commentator to offer insights at critical dramatic moments. An online pilot study evaluated acceptability of the Guide-Enhanced LSC (GELSC) and feasibility of Facebook advertising, streaming to smartphones, and retention. Facebook ads targeted high-HIV-prevalence areas. In 30 days, Facebook ads generated 230 screening interviews: 84 were high risk, 40 watched GELSC, and 39 followed up at 30 days. Recruitment of high-risk participants was 10 per week, compared to seven per week in previous field recruitment. Half the sample was Black; 12% were Latina. Findings suggest GELSC influenced sex scripts and behaviors. It was feasible to recruit young urban women from a large geographic area via Facebook and to retain the sample. We extended the reach to at-risk women by streaming to mobile devices.