HIV InfectionsPEP-2NCT00473018
Behavioral, Clinical and Basic Science Studies of Non-occupational Post-exposure Prophylaxis ("PEP-2")
A study testing standard versus enhanced risk reduction counseling in people with HIV Infections, run by University of California, San Francisco.
Trial summary
This is a randomized trial to compare the effect of standard versus enhanced risk reduction counseling on risk behavior incidence in individuals receiving PEP medications. The study seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk behaviors, STD incidence, and adherence to… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- standard versus enhanced risk reduction counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be included in the study the subject must be:
- >/= 14 years of age
- Able to give informed consent
- English- or Spanish-speaking
- Able to report risk of HIV exposure during the previous 72 hours defined as:
- unprotected sex defined as:
Show all 20Show fewer
- unprotected receptive or insertive anal or vaginal sex without a condom (with or without ejaculation); or
- protected receptive or insertive anal or vaginal intercourse with a condom which breaks or falls off during intercourse (with or without ejaculation); or
- sharing of potentially contaminated injection drug use equipment; or
- unprotected receptive oral sex with ejaculation; and this exposure was with a
- high risk partner defined as:
- known to be HIV-infected; or
- is a man who has sex with men; or
- is or has been an injection drug user; or
- is a sex worker, or
- the partner is anonymous, or
- the partner is known to the subject but their sexual or injection drug use history is unknown.
- Additional exposures will be considered if they involve potentially HIV-infected body fluids in contact with a mucous membrane or non-intact skin, at the discretion of the study clinician. The subject must report that he/she has never received antiretroviral medications for the treatment of established HIV infection nor been diagnosed with HIV infection. The subject must elect to initiate PEP medications.
- Index subjects will be allowed to enroll in the study up to four times in one year (re-PEP). They will be encouraged to participate in referrals for enhanced prevention services at the direction of the counseling supervisor. Subjects who enroll more than once will be given 2 additional counseling sessions for each re-enrollment episode designed to address issues related to on-going exposure.
- All women will be tested for pregnancy; if pregnant, they will still be offered enrollment in the study, with additional counseling provided by the Bay Area Perinatal Aids Center (BAPAC) at San Francisco General Hospital.
Who cannot join
- Subjects will be excluded if they are:
- Unable to give informed consent
- Known to be infected with HIV by their report
- Unable to commit to or make follow-up visits.
- Cases of sexual assault will be referred to rape counseling services. PEP may be offered as a non-study service in collaboration with the rape counseling services.
About this study
This is a randomized trial to compare the effect of standard versus enhanced risk reduction counseling on risk behavior incidence in individuals receiving PEP medications. The study seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk behaviors, STD incidence, and adherence to medications in individuals who receive enhanced risk reduction and adherence counseling and those who received standard risk reduction and adherence counseling; 2) evaluate viral and host biological factors involved in sexual transmission that may either influence PEP efficacy, or themselves be negatively or positively affected by the administration of PEP medications; and 3) contribute to the CDC registry in an attempt to provide crucial data for a case control analysis to establish the efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be the change in participants' number of unprotected sexual acts following administration of PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex, assessed at 12 months following a course of PEP, minus the number of unprotected acts the participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline). Methods to be used consist of interview data collection, questionnaires, risk reduction and adherence counseling and source recruitment counseling (index subject).
Read the detailed description
- SPECIFIC AIMS Our group (including behavioral, epidemiological, basic, and clinical scientists from UCSF, San Francisco General Hospital, The San Francisco Department of Public Health, and the UCSF-affiliated Gladstone Institute of Virology and Immunology) conducted a feasibility study of Post Exposure Prevention (PEP) in which we successfully recruited, retained, and assessed over 400 individuals recently and substantially exposed to HIV-1 (index cases), as well as a significant number of the persons (source cases) who exposed the index cases to HIV-1.
We are frequently asked by physicians and public health professionals for help in establishing similar programs in various communities. PEP has two promising possibilities: (a) it may prevent HIV infection and (b) it may be a viable way to attract high risk uninfected individuals into counseling. But tremendous uncertainty remains about how to integrate PEP into existing clinical and prevention programs. Because we felt that risk reduction counseling was essential to prevent disinhibition, we provided intensive (5 session) prevention counseling in our feasibility study. Adherence counseling was also essential as incomplete adherence could reduce the effectiveness of the medications or increase the chance of infection with a resistant isolate. However, multi-session counseling is very resource intensive.
The most urgent question to be addressed about PEP is whether PEP medications must be offered with an enhanced counseling program, or if standard HIV pre- and post-test counseling and routine adherence counseling will result in equivalent risk behavior following PEP and adherence with antiretroviral medications.
Thus, we propose the following primary aim:
- To conduct a randomized trial to determine whether enhanced (multi-session) risk reduction and adherence counseling is equivalent to standard (2 session) risk reduction and adherence counseling in terms of self-reported risk behaviors and documented STDs and adherence to PEP medications. In addition, because we are recruiting a cohort of HIV-infected individuals who are engaging in behavior potentially capable of transmitting HIV, as well as HIV uninfected individuals who have recently exposed themselves to HIV, we have the unique opportunity to address the following important aims:
- Source (HIV infected person potentially transmitting) virologic characteristics: To describe and compare the (a) HIV-1 RNA level and (b) antiretroviral resistance mutation prevalence in the plasma and genital secretions of source subjects.
- Index (exposed HIV uninfected) subject CD8+ T-cell antiviral factor activity responses:
- To determine whether PEP medications blunt CD8+ T-cell antiviral factor (CAF) activity by comparing the changes in CAF following HIV exposure in persons receiving PEP medications to individuals matched for exposure who do not receive medications;
- To determine whether there is a correlation between source plasma and genital secretion HIV-1 RNA levels and index CAF activity.)
- To evaluate the safety of adding 2 doses of nevirapine to the existing medication regimens that are based on two nucleoside analogue reverse transcriptase inhibitors ¬+ a protease inhibitor.
- Conditions
- HIV Infections
- Being tested
- standard versus enhanced risk reduction counseling
- Keywords
- postexposure prophylaxis, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard versus enhanced risk reduction counselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Michelle E Roland, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473018
- Sponsor's protocol ID
- 5R01MH061180
- Acronym
- PEP-2
- Status last verified
- May 2007
- First submitted
- 9 May 2007
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral, Clinical and Basic Science Studies of Non-occupational Post-exposure Prophylaxis ("PEP-2")
- ClinicalTrials.gov ID
- NCT00473018
- Acronym / sponsor ID
- PEP-2 / 5R01MH061180
- Conditions
- HIV Infections
- Keywords
- postexposure prophylaxis, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- First posted
- 14 May 2007 (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 is a randomized trial to compare the effect of standard versus enhanced risk reduction counseling on risk behavior incidence in individuals receiving PEP medications. The study seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk behaviors, STD incidence, and adherence to medications in individuals who receive enhanced risk reduction and adherence counseling and those who received standard risk reduction and adherence counseling; 2) evaluate viral and host biological factors involved in sexual transmission that may either influence PEP efficacy, or themselves be negatively or positively affected by the administration of PEP medications; and 3) contribute to the CDC registry in an attempt to provide crucial data for a case control analysis to establish the efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be the change in participants' number of unprotected sexual acts following administration of PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex, assessed at 12 months following a course of PEP, minus the number of unprotected acts the participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline). Methods to be used consist of interview data collection, questionnaires, risk reduction and adherence counseling and source recruitment counseling (index subject).
Detailed description
- SPECIFIC AIMS Our group (including behavioral, epidemiological, basic, and clinical scientists from UCSF, San Francisco General Hospital, The San Francisco Department of Public Health, and the UCSF-affiliated Gladstone Institute of Virology and Immunology) conducted a feasibility study of Post Exposure Prevention (PEP) in which we successfully recruited, retained, and assessed over 400 individuals recently and substantially exposed to HIV-1 (index cases), as well as a significant number of the persons (source cases) who exposed the index cases to HIV-1.
We are frequently asked by physicians and public health professionals for help in establishing similar programs in various communities. PEP has two promising possibilities: (a) it may prevent HIV infection and (b) it may be a viable way to attract high risk uninfected individuals into counseling. But tremendous uncertainty remains about how to integrate PEP into existing clinical and prevention programs. Because we felt that risk reduction counseling was essential to prevent disinhibition, we provided intensive (5 session) prevention counseling in our feasibility study. Adherence counseling was also essential as incomplete adherence could reduce the effectiveness of the medications or increase the chance of infection with a resistant isolate. However, multi-session counseling is very resource intensive.
The most urgent question to be addressed about PEP is whether PEP medications must be offered with an enhanced counseling program, or if standard HIV pre- and post-test counseling and routine adherence counseling will result in equivalent risk behavior following PEP and adherence with antiretroviral medications.
Thus, we propose the following primary aim:
- To conduct a randomized trial to determine whether enhanced (multi-session) risk reduction and adherence counseling is equivalent to standard (2 session) risk reduction and adherence counseling in terms of self-reported risk behaviors and documented STDs and adherence to PEP medications. In addition, because we are recruiting a cohort of HIV-infected individuals who are engaging in behavior potentially capable of transmitting HIV, as well as HIV uninfected individuals who have recently exposed themselves to HIV, we have the unique opportunity to address the following important aims:
- Source (HIV infected person potentially transmitting) virologic characteristics: To describe and compare the (a) HIV-1 RNA level and (b) antiretroviral resistance mutation prevalence in the plasma and genital secretions of source subjects.
- Index (exposed HIV uninfected) subject CD8+ T-cell antiviral factor activity responses:
- To determine whether PEP medications blunt CD8+ T-cell antiviral factor (CAF) activity by comparing the changes in CAF following HIV exposure in persons receiving PEP medications to individuals matched for exposure who do not receive medications;
- To determine whether there is a correlation between source plasma and genital secretion HIV-1 RNA levels and index CAF activity.)
- To evaluate the safety of adding 2 doses of nevirapine to the existing medication regimens that are based on two nucleoside analogue reverse transcriptase inhibitors ¬+ a protease inhibitor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- >/= 14 years of age
- Able to give informed consent
- English- or Spanish-speaking
- Able to report risk of HIV exposure during the previous 72 hours defined as:
- Index subjects will be allowed to enroll in the study up to four times in one year (re-PEP). They will be encouraged to participate in referrals for enhanced prevention services at the direction of the counseling supervisor. Subjects who enroll more than once will be given 2 additional counseling sessions for each re-enrollment episode designed to address issues related to on-going exposure.
Key exclusion criteria (5 listed)
- Unable to give informed consent
- Known to be infected with HIV by their report
- Unable to commit to or make follow-up visits.
- Cases of sexual assault will be referred to rape counseling services. PEP may be offered as a non-study service in collaboration with the rape counseling services.
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 |
|---|---|---|
| standard versus enhanced risk reduction counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Jun 2015.
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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. This study is not recruiting at the moment.
Michelle E Roland principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing standard versus enhanced risk reduction counseling in people with HIV Infections, run by University of California, San Francisco.
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 20 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 2 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.