Alcohol Misuse, HIV, Pre-exposure Prophylaxis, Sexually Transmitted Infections
Conditions
Brief summary
The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol. The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation. Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.
Detailed description
Up to 500 participants who are human immunodeficiency virus (HIV)-negative who engage in heavy alcohol use will be enrolled and referred to their local health departments for pre-exposure prophylaxis (PrEP). Primary biobehavioral outcomes assessed will include reduced alcohol use (self-reported and biological, including phosphatidylethanol \[PEth\]), increased PrEP uptake (self-reported and biological), and reduced sexual risk (self-reported condomless sex and impaired sex and biological testing for HIV) at 3- and 6-month follow-up.
Interventions
BEHAVIORALmHealth-Women's CoOp
The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and violence through education, skills-building, and role-play and rehearsal via a mobile app. The mHealth-Women's CoOp app is also used to help participants monitor progress toward their goals throughout the study period. Specifically, the app is programmed to prompt the user, to visit the app and participate in several activities, including health and behavior check-in and revisiting aspects of the mHealth-Women's CoOp educational content to sustain risk reduction.
BEHAVIORALVirtual Group
The enhanced online group component will be available to be accessed using the mHealth-Women's CoOp platform for participants in the enhanced arm. The purpose of this component is to allow for young women who use alcohol to interact with young women like them and also discuss issues related to substance use and sexual risk-taking via a guided conversation to allow for motivational and informational support. The virtual group component will include online live discussions moderated and monitored by a trained online facilitator.
Sponsors
RTI International
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
Selected Inclusion Criteria: * identify as Black/African American * identify as female * be between 18 and 30 years old * recent substance use * HIV negative and not currently on PrEP * have an Android or iOS-based smartphone Selected
Exclusion criteria
* test positive for HIV * participated in the previous study activities of the current study or previous related studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol (Biological) | Baseline | Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. The One Step Ethyl Glucuronide (EtG) Test Dip Card is a lateral flow chromatographic immunoassay. Each test has a control line region to serve as a procedural control and a test line region; results with only a line in the control region and without a line in the test region are classified as positive. Urine EtG ≥300 ng/mL indicates a positive result. |
| Alcohol (Self-Reported) | Baseline | Revised Risk Behavior Assessment (RRBA): Volume (grams of ethanol, accounting for different standard drink size), frequency of use, frequency of binge, heavy episodic drinking (4+ drinks/day). |
| Sexual Risk: HIV (Biological) | Baseline | Number of participants living with HIV as assessed by OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test with oral fluid, with an approximate 99.3% sensitivity \& 99.8% specificity, which detects antibodies to HIV-1 and HIV-2. |
| Sexual Risk (Self-reported) | Baseline | Revised Risk Behavior Assessment (RRBA): Condomless vaginal or anal sex, impaired sex (AOD use prior to or during sex), casual partners, sex trading, \& concurrent partners (≥2 partners), other contraceptive use, \& perception of risk, HIV, recent STIs |
| PrEP Utilization (Biological) | 3-month | Dried blood spot (DBS) samples will be analyzed by quantification of drug concentrations by liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology using assays validated at the study laboratory. |
| PrEP Utilization (Self-Reported) | Baseline | Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Use (Biological) | Baseline | Easy@Home Multi-Drug Screen Test: Rapid urine-based drug screen to detect metabolites of recent drug use (\>99% correlation to gas chromatography at 95% confidence level) 10-panel-amphetamine, benzodiazepines, barbiturates, cocaine, opiates, methamphetamine, ecstasy, methadone, phencyclidine, and marijuana. Each test has a control line region to serve as a procedural control and a test line region; results with only a line in the control region and without a line in the test region are classified as positive. Concentrations at or above the following cutoff concentrations indicate a positive result for the following substances: amphetamine (1000 ng/mL), benzodiazepines (300 ng/mL), barbiturates (300 ng/mL), cocaine (300 ng/mL), opiates (2000 ng/mL), methamphetamine (1000 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL). |
| Drug Use (Self-Reported) | Baseline | The World Health Organization's Alcohol, Smoking \& Substance Use Involvement Scale (ASSIST) assesses risk for problems with drugs-such as marijuana, cocaine, amphetamine, and opioids-via 8 items. Scores range from 0 to 39, and this score indicates level of risk for drug use problems. Scores from 0 to 3 indicate lower risk for drug use problems, scores from 4 to 26 indicate moderate risk, and scores from 27 to 39 indicate high risk. |
| Perceived social support | Baseline | Multidimensional Scale of Perceived Social Support assesses perceived social support Multidimensional Scale of Perceived Social Support assesses perceived social support from family, friends, and others across a 12-item scale. Each item uses a 7-point scale (1 = very strongly disagree, 7 = very strongly agree). Items are summed and the total score is divided by the number of items. Scores range from 0 to 7. Higher scores indicate higher levels of social support. |
| Violence | Baseline | Adaptation of the World Health Organization (WHO) violence scale: Self-reported occurrence of emotional, physical, and sexual violence with an additional financial abuse query, all combined into a 16-item scale. Each item uses a 3-point response scale (1 = Never, 2 = Sometimes, 3 = Frequently). Items are summed, and scores range from 16 to 48. Higher scores indicate more frequent occurrences of violence. |
Countries
United States
Contacts
CONTACTFelicia A Browne, ScD, MPH
PRINCIPAL_INVESTIGATORFelicia A Browne, ScD, MPH
RTI International
Outcome results
None listed