Sexually Transmitted DiseasesPACTNCT01690494
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders
A study testing PACT and TAU in people with Sexually Transmitted Diseases and Unsafe Sex, run by Columbia University at 1 site in United States.
Trial summary
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Unsafe Sex, Substance-Related Disorders
- What is being tested?
- PACT and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2013to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Couples
- Both partners are aged 18 or older
- Identify each other as their primary sexual partner of opposite sex
- Relationship has existed at least 3 months
- At least one partner reports having unprotected vaginal or anal intercourse with the other partner in the past 90 days
- At least one partner reports exposure to an outside HIV risk in the past year
- Male partner reports and is verified by court records of being charged with a misdemeanor
- Male partner is currently under court supervision or probation
Who cannot join
- Either partner shows evidence of significant psychiatric or could impairment as confirmed by the MacArthur Competence Assessment Tool during the screening eligibility interview.
- Either partner reports severe physical or sexual violence perpetrated by the other partner in the past year as measured on the Revised Conflict Tactics Scale
- Either partner is unable to commit to participate in the study through to completion
- Either partner reports that the couple is planning a pregnancy within the next 12 months
- Either partner is not fluent in English as determined during Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
Read the detailed description
HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical intersecting public health issues for drug-involved men. Low income, Black and Hispanic men especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data suggest that the health disparity in HIV rates is actually increasing for Black men: current estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time. These HIV/STI transmission risks are fueled by high rates of poverty, incarceration, unemployment, and lack of access to health care and prevention services. The proposed study thus targets an underserved population at the epicenter of the epidemic in the U.S.
- Being tested
- PACT, TAU
- Keywords
- STI, sexually transmitted infection, HIV, criminal justice, probation, couples, drug use
- Medical subject headings
- Sexually Transmitted Diseases, Unsafe Sex, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACTBehavioural
Couple-based behavioral HIV/STI preventive intervention
TAUBehavioural
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
| Study group | Role | What they receive |
|---|---|---|
| PACT + TAU | Experimental | 4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant Receives: Behavioral: PACT; Behavioral: TAU |
| TAU | Active comparator | TAU control condition delivered to the male participant Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biologically confirmed sexually transmitted infections
Measured: Baseline and up to 12 months post intervention
Change in proportion of unprotected sexual acts
Measured: Baseline and up to 12 months post intervention
Secondary outcomes (3)
Change in drug use
Measured: Baseline and up to 12 months post intervention
Change in utilization of drug treatment
Measured: Baseline and up to 12 months post intervention
Change in recidivism
Measured: Up to 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study start11 Jun 2013
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nabila El-Bassel, PhD, Columbia University
- Investigators
- Nabila El-Bassel, DSW, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690494
- Sponsor's protocol ID
- AAAK0206
- Other IDs
- 1R01DA033168-01A1
- Acronym
- PACT
- Status last verified
- Jul 2018
- First submitted
- 19 Sep 2012
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.
PubMed 21725249Goddard-Eckrich D, Sardana SM, Henry BF, Downey DL, Gilbert L, Stringer KL, Chang M, Wu E, Thomas BV, Bolden LA, Mckenna N, Abbas BT, Prichard C, Baholli B, El-Bassel N, Hunt T. "Why not take that pill?": A Mixed-Methods Study of Gender, Risk Perception, and PrEP Uptake Among Drug-Involved Heterosexual Couples Under Community Supervision. AIDS Behav. 2026 Jun 29. doi: 10.1007/s10461-026-05169-4. Online ahead of print.
PubMed 42366304Wimberly AS, Rose R, Levin K, Goddard-Eckrich D, Gilbert L, Wu E, Dasgupta A, Hunt T, Henry BF, El-Bassel N. Traumatic Life Events and Stressors: Associations With Substance Use Problems of Men Under Community Supervision. J Correct Health Care. 2023 Jun;29(3):190-197. doi: 10.1089/jchc.21.12.0137. Epub 2023 Apr 28.
PubMed 37116052El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Goodwin S, Tibbetts R, Almonte-Weston M, Hunt T. Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191139. doi: 10.1001/jamanetworkopen.2019.1139.
PubMed 30924895
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
- ClinicalTrials.gov ID
- NCT01690494
- Acronym / sponsor ID
- PACT / AAAK0206
- Keywords
- STI, sexually transmitted infection, HIV, criminal justice, probation, couples, drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 21 Sep 2012 (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.
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
Detailed description
HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical intersecting public health issues for drug-involved men. Low income, Black and Hispanic men especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data suggest that the health disparity in HIV rates is actually increasing for Black men: current estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time. These HIV/STI transmission risks are fueled by high rates of poverty, incarceration, unemployment, and lack of access to health care and prevention services. The proposed study thus targets an underserved population at the epicenter of the epidemic in the U.S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACT + TAU | Experimental | Behavioral: PACT, Behavioral: TAU4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant |
| TAU | Active comparator | Behavioral: TAUTAU control condition delivered to the male participant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Couples
- Both partners are aged 18 or older
- Identify each other as their primary sexual partner of opposite sex
- Relationship has existed at least 3 months
- At least one partner reports having unprotected vaginal or anal intercourse with the other partner in the past 90 days
Key exclusion criteria (5 listed)
- Either partner shows evidence of significant psychiatric or could impairment as confirmed by the MacArthur Competence Assessment Tool during the screening eligibility interview.
- Either partner reports severe physical or sexual violence perpetrated by the other partner in the past year as measured on the Revised Conflict Tactics Scale
- Either partner is unable to commit to participate in the study through to completion
- Either partner reports that the couple is planning a pregnancy within the next 12 months
- Either partner is not fluent in English as determined during Informed Consent
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 |
|---|---|---|
| PACTCouple-based behavioral HIV/STI preventive intervention | Behavioural | PACT + TAU |
| TAUStandard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites | Behavioural | PACT + TAU, TAU |
Primary outcome
Change in biologically confirmed sexually transmitted infections
Time frame: Baseline and up to 12 months post intervention
Change in proportion of unprotected sexual acts
Time frame: Baseline and up to 12 months post intervention
3 secondary outcomes
Change in drug use
Time frame: Baseline and up to 12 months post intervention
Change in utilization of drug treatment
Time frame: Baseline and up to 12 months post intervention
Change in recidivism
Time frame: Up to 12 months post intervention
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 18 Jul 2018.
- Background: PubMed 21725249El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.
- Derived from this study: PubMed 42366304Goddard-Eckrich D, Sardana SM, Henry BF, Downey DL, Gilbert L, Stringer KL, Chang M, Wu E, Thomas BV, Bolden LA, Mckenna N, Abbas BT, Prichard C, Baholli B, El-Bassel N, Hunt T. "Why not take that pill?": A Mixed-Methods Study of Gender, Risk Perception, and PrEP Uptake Among Drug-Involved Heterosexual Couples Under Community Supervision. AIDS Behav. 2026 Jun 29. doi: 10.1007/s10461-026-05169-4. Online ahead of print.
- Derived from this study: PubMed 37116052Wimberly AS, Rose R, Levin K, Goddard-Eckrich D, Gilbert L, Wu E, Dasgupta A, Hunt T, Henry BF, El-Bassel N. Traumatic Life Events and Stressors: Associations With Substance Use Problems of Men Under Community Supervision. J Correct Health Care. 2023 Jun;29(3):190-197. doi: 10.1089/jchc.21.12.0137. Epub 2023 Apr 28.
- Derived from this study: PubMed 30924895El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Goodwin S, Tibbetts R, Almonte-Weston M, Hunt T. Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191139. doi: 10.1001/jamanetworkopen.2019.1139.
- Individual participant dataSharing planned: Undecided
Related trials for Sexually Transmitted Diseases
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 recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
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.
Nabila El-Bassel, DSW principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACT and TAU in people with Sexually Transmitted Diseases and Unsafe Sex, run by Columbia University 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 8 inclusion and 5 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 18 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 biologically confirmed sexually transmitted infections (time frame: Baseline and up to 12 months post intervention). 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?
On the ClinicalTrials.gov record for NCT01690494, which also lists 4 linked publications.
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 Jul 2018.