HIVP&TNCT01935440
A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives
A study testing Prevention & Testing in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Prevention & Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Index
- 18 years old or older
- documentation of HIV positive status
- report one of following risk behaviors in past 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex
- Testing network
- 18 or older
Show all 14Show fewer
- provided testing coupon provided by an index participant
- Longitudinal network participant-
- tested HIV negative at the Lighthouse via redeeming a testing coupon
- reported interacting with index who gave the coupon at least weekly
- report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex
- Positive Networks
- HIV positive
- report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex
Who cannot join
- Index- already enrolled in the study as a Network participant
- Testing network- already enrolled in the study as a Network participant
- Longitudinal network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant
- Positive network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighhouse Studies @ Peer Point
Baltimore, Maryland, 21205
About this study
The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.
Read the detailed description
The primary objective of this funded research is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators to: (1) recruit their high risk social network members for voluntary HIV counseling and testing (VCT) at the research clinic, (2) promote risk reduction among social network members, and (3) promote engagement in HIV care by encouraging HIV seropositive network members to schedule and keep HIV primary care appointments. There will be four types of participants in the Full Trial: 1) Index, 2) Testing Network 3) Longitudinal Network and 4) HIV positive network participants. This longitudinal study includes baseline, 6-months, and 12-month assessments
- Conditions
- HIV
- Being tested
- Prevention & Testing, Prevention & Testing Control
- Keywords
- HIV, drug use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention & TestingBehavioural
6 group sessions, 1 individual session, and 1 dyad session
Prevention & Testing ControlBehavioural
7 group sessions
| Study group | Role | What they receive |
|---|---|---|
| Prevention & Testing Control | Active comparator | The comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose. Receives: Behavioral: Prevention & Testing Control |
| Prevention & Testing Intervention | Experimental | The intervention condition is training on peer outreach skills which includes talking to HIV positive social network members about HIV care, medication adherence and HIV risk reduction. Receives: Behavioral: Prevention & Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HIV medication adherence
Measured: 6 month
change in frequency in attending HIV medical appointments
Measured: 6 month
Secondary outcomes (2)
change in sharing injection equipment
Measured: 6 month
change in condom use
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study start1 Nov 2012
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carl Latkin, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Carl A Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935440
- Sponsor's protocol ID
- R01DA032217
- Other IDs
- R01DA032217
- Acronym
- P&T
- Status last verified
- Jul 2018
- First submitted
- 20 Aug 2013
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives
- ClinicalTrials.gov ID
- NCT01935440
- Acronym / sponsor ID
- P&T / R01DA032217
- Conditions
- HIV
- Keywords
- HIV, drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 5 Sep 2013 (estimated)
- 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.
The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.
Detailed description
The primary objective of this funded research is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators to: (1) recruit their high risk social network members for voluntary HIV counseling and testing (VCT) at the research clinic, (2) promote risk reduction among social network members, and (3) promote engagement in HIV care by encouraging HIV seropositive network members to schedule and keep HIV primary care appointments. There will be four types of participants in the Full Trial: 1) Index, 2) Testing Network 3) Longitudinal Network and 4) HIV positive network participants. This longitudinal study includes baseline, 6-months, and 12-month assessments
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention & Testing Control | Active comparator | Behavioral: Prevention & Testing ControlThe comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose. |
| Prevention & Testing Intervention | Experimental | Behavioral: Prevention & TestingThe intervention condition is training on peer outreach skills which includes talking to HIV positive social network members about HIV care, medication adherence and HIV risk reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Index
- 18 years old or older
- documentation of HIV positive status
- report one of following risk behaviors in past 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex
- Testing network
Key exclusion criteria (4 listed)
- Index- already enrolled in the study as a Network participant
- Testing network- already enrolled in the study as a Network participant
- Longitudinal network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant
- Positive network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant
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 |
|---|---|---|
| Prevention & Testing6 group sessions, 1 individual session, and 1 dyad session | Behavioural | Prevention & Testing Intervention |
| Prevention & Testing Control7 group sessions | Behavioural | Prevention & Testing Control |
Primary outcome
change in HIV medication adherence
Time frame: 6 month
change in frequency in attending HIV medical appointments
Time frame: 6 month
2 secondary outcomes
change in sharing injection equipment
Time frame: 6 month
change in condom use
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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. This study is not recruiting at the moment.
Carl A Latkin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention & Testing in people with HIV, run by Johns Hopkins Bloomberg School of Public Health 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HIV medication adherence (time frame: 6 month). The study lists 2 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 9 Jul 2018.