HIV Pre-exposure ProphylaxisNCT06799702
Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)
A study testing Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID) in people with HIV Pre-exposure Prophylaxis and HEPATITIS C (HCV), run by University of Georgia at 1 site in United States.
Trial summary
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV), Opioid Use Disorder
- What is being tested?
- Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who actively inject drugs verified by visible injection stigmata (needle tracks)
- HIV negative
- Adult (≥18 years)
- lives in rural areas
Who cannot join
- Living with HIV
- Lives in urban areas
- Not proficient in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.
Read the detailed description
The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.
- Being tested
- Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)
- Keywords
- HIV Pre-Exposure Prophylaxis, Hepatitis C Virus, Medications for Opioid Use Disorder, People who inject drugs (PWID), Deep South, Telehealth Intervention
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)Behavioural
The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.
g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Receives: Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID) |
| Waitlist Control | Active comparator | Control Receives: Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation/drop-out rates of the PWID.
Measured: Months 31-60
Acceptability of the telehealth intervention
Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., "convenient," "a nuisance," "easy to use," and "time-consuming."
Measured: Months 31-60
Usability of the telehealth intervention
Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.
Measured: Months 31-60
Secondary outcomes (5)
Depressive symptoms
The Center for Epidemiologic Studies Depression (CES-D) Scale (20 items) will be used to measure depressive symptoms. CES-D Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Months 31-60
Resilience
The 10-item Connor-Davidson Resilience Scale (CD-RISC) scale will be used to measure resilience. Scores range from 0-40, where higher scores indicate greater resilience.
Measured: Months 31-60
Intersecting stigma of HIV, HCV, and drug use
The 16-item Anticipated HIV Stigma Scale will be used to measure HIV stigma. Scores range from 16-64, where higher scores reflect higher stigma. The 33-item HCV Stigma Scale (HCV-SS) will be used to measure HCV-related stigma. The total score range for this scale is 33 to 132, with higher scores indicating greater perceived stigma. The 8-item Perceived Stigma of Substance Abuse Scale (PSAS) will be used to measure the drug use stigma. Scores range from 8-32, where a higher score reflects higher stigma. Intersectional stigma scores will be calculated using the formula, d = square root of (a-squared + b-squared + c-squared), where d is the intersectional stigma score, and a is the HIV-related stigma score, b is the HCV-related stigma score, and c is the drug use stigma score. The score ranges from 37.5-150.2, and the higher the score, the higher the intersecting stigma.
Measured: Months 31-60
Sexual behavior
Sexual practices like protected sex, risky sex (sex under the influence, sex in return of drugs/money, unprotected anal/vaginal sex, multiple partners, not knowing partnmer's HIV status)
Measured: Months 31-60
Risky Injection Bheavior
Risky injection behavior includes the sharing of syringes, using same syringe multiple times
Measured: Months 31-60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mohammad Rifat Haider, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799702
- Sponsor's protocol ID
- PROJECT000009015
- Other IDs
- K01DA059329
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will not share the IPD of the participants of this study due to the risk of privacy breach for the participants.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South
- ClinicalTrials.gov ID
- NCT06799702
- Acronym / sponsor ID
- PROJECT000009015
- Keywords
- HIV Pre-Exposure Prophylaxis, Hepatitis C Virus, Medications for Opioid Use Disorder, People who inject drugs (PWID), Deep South, Telehealth Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.
Detailed description
The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)Intervention |
| Waitlist Control | Active comparator | Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People who actively inject drugs verified by visible injection stigmata (needle tracks)
- HIV negative
- Adult (≥18 years)
- lives in rural areas
Key exclusion criteria (3 listed)
- Living with HIV
- Lives in urban areas
- Not proficient in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e. g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks. | Behavioural | Intervention, Waitlist Control |
Primary outcome
Feasibility of the Intervention
Time frame: Months 31-60
Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation/drop-out rates of the PWID.
Acceptability of the telehealth intervention
Time frame: Months 31-60
Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., "convenient," "a nuisance," "easy to use," and "time-consuming."
Usability of the telehealth intervention
Time frame: Months 31-60
Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.
5 secondary outcomes
Depressive symptoms
Time frame: Months 31-60
Resilience
Time frame: Months 31-60
Intersecting stigma of HIV, HCV, and drug use
Time frame: Months 31-60
Sexual behavior
Time frame: Months 31-60
Risky Injection Bheavior
Time frame: Months 31-60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. Investigators will not share the IPD of the participants of this study due to the risk of privacy breach for the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID) in people with HIV Pre-exposure Prophylaxis and HEPATITIS C (HCV), run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Rifat Haider, Ph.D. (803-477-4289, haider@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Months 31-60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.