HIV InfectionsNCT00995176
The Women's HIV SeroIncidence Study (ISIS)
An observational study of HIV Infections, run by HIV Prevention Trials Network at 9 sites in United States.
Trial summary
Approximately 30 percent of new HIV infections in the Unites States occur in women, with a disproportionate number occurring in women of color. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 2,099 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2009to Mar 2011
- Phase
- Observational
- 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
Study population: Men and women residing in areas from defined geographic areas with high HIV prevalence and poverty
Who may be able to join
- Self identify as a woman
- 18 to 44 years of age, inclusive on the date of screening
- Willing to receive HIV test results
- Resides in a designated study community
- Has engaged in unprotected (e.g. without a condom) vaginal and/or anal sex with a man during the prior 6 months
- At least one of the following criteria:
Show all 25Show fewer
- Illicit injected and/or noninjected drug use (e.g. heroin, cocaine, crack cocaine, methamphetamine, and/or prescription drugs used outside the oversight of a medical professional) within 6 months. Participants whose only illicit drug use is marijuana do not meet the illicit drug use eligibility criteria.
- Alcohol dependence (within 6 months)
- Binge drinking defined as four or more drinks at one time (e.g. during the morning, afternoon or evening) within 6 months
- Incarceration within 5 years (jail and/or prison)
- STI (gonorrhea, Chlamydia, trichomonas, or syphilis) within 6 months
- Exchange of sex for commodities (e.g. drugs, money, shelter) within 6 months
- Male sexual partner within 6 months with any history of self-reported use of illicit injected or noninjected drugs within 6 months, incarceration (within 5 years), STIs (within 6 months), HIV-infected diagnosis, or history of binge drinking defined as 5 or more drinks at one time (within 6 months) and/or alcohol dependence (within 6 months)
- Self identify as a man
- 18 years of age or older
- Resides in a designated community
- Unprotected vaginal and/or anal sex with a woman during the prior 6 months
- At least one of the following criteria:
- Illicit injected and/or noninjected drug use within 6 months
- Alcohol dependence (within 6 months)
- Binge drinking defined as five or more drinks at one time (e.g. during the morning, afternoon or evening) within 6 months
- Incarceration (within 5 years, including jail and/or prison)
- STI within 6 months
- Exchange of sex for commodities
- HIV-infected
Who cannot join
- History of prior HIV-infected diagnosis
- Planning on moving out of state within the study follow-up period or traveling out of state for more than 2 consecutive months during the study follow-up period
- Current enrollment in an HIV prevention trial
- Current or past participation in an HIV vaccine trial
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Ponce de Leon Center
Atlanta, Georgia, 30308
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
Harlem Prevention Ctr. CRS
New York, New York, 10027
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, 07103
Wake County Health and Human Services
Raleigh, North Carolina, 27630
Bronx- Lebanon Hospital Center Clinical Research Site
The Bronx, New York, 10452
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Approximately 30 percent of new HIV infections in the Unites States occur in women, with a disproportionate number occurring in women of color. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.
Read the detailed description
In 1985 women accounted for only 8 percent of new AIDS diagnoses in the United States. Today women are estimated to account for nearly 30 percent of the people who are diagnosed with new HIV infections (incidence). A disproportionate amount of those infections (80 percent) occur among Black and Hispanic girls and women. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.
Research teams will conduct eligibility screening interviews with women whom they have encountered in various locations within the study communities. Eligibility screenings, as well as subsequent study visits, will take place in a variety of mutually agreeable locations that are capable of providing both privacy and confidentiality. Examples include clinics, mobile vans, community organizations or other appropriate public places. The eligibility interview contains topics related to sexual behavior, drug and alcohol use, incarceration history and previous STI diagnosis and treatment. Information about where the potential participant resides and her current sexual partners will also be gathered.
The women who are found to be eligible will be asked to provide a blood sample for HIV and other investigational testing. They will also be asked to participate in a longer interview. All participants will receive HIV risk-reduction counseling, free condoms and appropriate referrals. Monthly contact will be maintained with participants through information that was provided upon enrollment. A phone number that participants can use to contact the research team will also be provided. Monthly calls will each last about 5 to 15 minutes.
About six months after enrolling each participant will be scheduled to have another in-person visit with study staff to complete an interview similar to the eligibility interview. Women who have tested HIV negative will be asked to provide another blood sample for HIV testing during that same period of time, while women who are living with HIV will be asked to provide blood samples to evaluate their HIV-related health. Women who enroll during the earliest portion of the study may be asked to complete a second visit in another six months. Those women will continue to receive monthly contacts between the dates of their first and second visits.
In addition to the primary participant group, a small group of women from four of the study communities will also be recruited to participate in interviews and focus groups that will cover issues similar to the topics included in the eligibly screening. A small group of men from those same four study communities will also be recruited to participate in similar focus groups.
- Conditions
- HIV Infections
- Keywords
- Prevention, HIV, 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women residing in areas from defined geographic areas with high HIV prevalence and poverty | |
| 2 | Men residing in areas from defined geographic areas with high HIV prevalence and poverty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the overall HIV-1 incidence rate among 2,000 women in the US from defined geographic areas with high HIV prevalence and poverty
Measured: Throughout study
Secondary outcomes (6)
Evaluation of laboratory assays for HIV-1 incidence determination
Measured: Throughout study
Estimation of recruitment and retention rates
Measured: Throughout study
Assessment of women's preferred recruitment and retention strategies for future studies
Measured: Throughout study
Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies
Measured: Throughout study
Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive
Measured: Throughout study
Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sally Hodder, MD, Study chair, UMDNJ - New Jersey Medical SchoolJessica Justman, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995176
- Sponsor's protocol ID
- HPTN 064
- Other IDs
- 1U01AI068619
- Status last verified
- Aug 2022
- First submitted
- 14 Oct 2009
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data was collated into manuscripts by the statistical and data management center for the HPTN.
Publications
Hodder SL, Justman J, Haley DF, Adimora AA, Fogel CI, Golin CE, O'Leary A, Soto-Torres L, Wingood G, El-Sadr WM; HIV Prevention Trials Network Domestic Prevention in Women Working Group. Challenges of a hidden epidemic: HIV prevention among women in the United States. J Acquir Immune Defic Syndr. 2010 Dec;55 Suppl 2(Suppl 2):S69-73. doi: 10.1097/QAI.0b013e3181fbbdf9.
PubMed 21406990Haley DF, Justman JE. The HIV epidemic among women in the United States: a persistent puzzle. J Womens Health (Larchmt). 2013 Sep;22(9):715-7. doi: 10.1089/jwh.2013.4562. No abstract available.
PubMed 24007379Haley DF, Lucas J, Golin CE, Wang J, Hughes JP, Emel L, El-Sadr W, Frew PM, Justman J, Adimora AA, Watson CC, Mannheimer S, Rompalo A, Soto-Torres L, Tims-Cook Z, Carter Y, Hodder SL; HPTN 064 Study Team. Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064). AIDS Patient Care STDS. 2014 Apr;28(4):206-17. doi: 10.1089/apc.2013.0366.
PubMed 24697160Eshleman SH, Hughes JP, Laeyendecker O, Wang J, Brookmeyer R, Johnson-Lewis L, Mullis CE, Hackett J Jr, Vallari AS, Justman J, Hodder S. Use of a multifaceted approach to analyze HIV incidence in a cohort study of women in the United States: HIV Prevention Trials Network 064 Study. J Infect Dis. 2013 Jan 15;207(2):223-31. doi: 10.1093/infdis/jis658. Epub 2012 Nov 5.
PubMed 23129758Hodder SL, Justman J, Hughes JP, Wang J, Haley DF, Adimora AA, Del Rio C, Golin CE, Kuo I, Rompalo A, Soto-Torres L, Mannheimer SB, Johnson-Lewis L, Eshleman SH, El-Sadr WM; HIV Prevention Trials Network 064; Women's HIV SeroIncidence Study Team. HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med. 2013 Jan 1;158(1):10-8. doi: 10.7326/0003-4819-158-1-201301010-00004.
PubMed 23277896Adimora AA, Hughes JP, Wang J, Haley DF, Golin CE, Magnus M, Rompalo A, Justman J, del Rio C, El-Sadr W, Mannheimer S, Soto-Torres L, Hodder SL; HPTN 064 Protocol Team. Characteristics of multiple and concurrent partnerships among women at high risk for HIV infection. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):99-106. doi: 10.1097/QAI.0b013e3182a9c22a.
PubMed 24056163Haley DF, Golin C, El-Sadr W, Hughes JP, Wang J, Roman Isler M, Mannheimer S, Kuo I, Lucas J, DiNenno E, Justman J, Frew PM, Emel L, Rompalo A, Polk S, Adimora AA, Rodriquez L, Soto-Torres L, Hodder S. Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt). 2014 Jun;23(6):541-51. doi: 10.1089/jwh.2013.4654. Epub 2014 Apr 17.
PubMed 24742266Kuo I, Golin CE, Wang J, Haley DF, Hughes J, Mannheimer S, Justman J, Rompalo A, Frew PM, Adimora AA, Soto-Torres L, Hodder S; HPTN 064 Study Team. Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend. 2014 Jun 1;139:93-9. doi: 10.1016/j.drugalcdep.2014.03.007. Epub 2014 Mar 19.
PubMed 24698079Abrams JA, Odlum M, Tillett E, Haley D, Justman J, Hodder S, Vo L, O'Leary A, Frew PM; HIV Prevention Trials Network 064 (HTPN) Study Team. Strategies for increasing impact, engagement, and accessibility in HIV prevention programs: suggestions from women in urban high HIV burden counties in the Eastern United States (HPTN 064). BMC Public Health. 2020 Sep 3;20(1):1340. doi: 10.1186/s12889-020-09426-6.
PubMed 32883248Frew PM, Parker K, Vo L, Haley D, O'Leary A, Diallo DD, Golin CE, Kuo I, Soto-Torres L, Wang J, Adimora AA, Randall LA, Del Rio C, Hodder S; HIV Prevention Trials Network 064 (HTPN) Study Team. Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064). BMC Public Health. 2016 Aug 17;16(1):803. doi: 10.1186/s12889-016-3364-7.
PubMed 27530401
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Women's HIV SeroIncidence Study (ISIS)
- ClinicalTrials.gov ID
- NCT00995176
- Acronym / sponsor ID
- HPTN 064
- Conditions
- HIV Infections
- Keywords
- Prevention, HIV, HIV seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,099 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Oct 2009 (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.
Approximately 30 percent of new HIV infections in the Unites States occur in women, with a disproportionate number occurring in women of color. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.
Detailed description
In 1985 women accounted for only 8 percent of new AIDS diagnoses in the United States. Today women are estimated to account for nearly 30 percent of the people who are diagnosed with new HIV infections (incidence). A disproportionate amount of those infections (80 percent) occur among Black and Hispanic girls and women. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.
Research teams will conduct eligibility screening interviews with women whom they have encountered in various locations within the study communities. Eligibility screenings, as well as subsequent study visits, will take place in a variety of mutually agreeable locations that are capable of providing both privacy and confidentiality. Examples include clinics, mobile vans, community organizations or other appropriate public places. The eligibility interview contains topics related to sexual behavior, drug and alcohol use, incarceration history and previous STI diagnosis and treatment. Information about where the potential participant resides and her current sexual partners will also be gathered.
The women who are found to be eligible will be asked to provide a blood sample for HIV and other investigational testing. They will also be asked to participate in a longer interview. All participants will receive HIV risk-reduction counseling, free condoms and appropriate referrals. Monthly contact will be maintained with participants through information that was provided upon enrollment. A phone number that participants can use to contact the research team will also be provided. Monthly calls will each last about 5 to 15 minutes.
About six months after enrolling each participant will be scheduled to have another in-person visit with study staff to complete an interview similar to the eligibility interview. Women who have tested HIV negative will be asked to provide another blood sample for HIV testing during that same period of time, while women who are living with HIV will be asked to provide blood samples to evaluate their HIV-related health. Women who enroll during the earliest portion of the study may be asked to complete a second visit in another six months. Those women will continue to receive monthly contacts between the dates of their first and second visits.
In addition to the primary participant group, a small group of women from four of the study communities will also be recruited to participate in interviews and focus groups that will cover issues similar to the topics included in the eligibly screening. A small group of men from those same four study communities will also be recruited to participate in similar focus groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women residing in areas from defined geographic areas with high HIV prevalence and poverty |
| 2 | – | –Men residing in areas from defined geographic areas with high HIV prevalence and poverty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women residing in areas from defined geographic areas with high HIV prevalence and poverty
Key inclusion criteria (25 listed)
- Self identify as a woman
- 18 to 44 years of age, inclusive on the date of screening
- Willing to receive HIV test results
- Resides in a designated study community
- Has engaged in unprotected (e.g. without a condom) vaginal and/or anal sex with a man during the prior 6 months
Key exclusion criteria (6 listed)
- History of prior HIV-infected diagnosis
- Planning on moving out of state within the study follow-up period or traveling out of state for more than 2 consecutive months during the study follow-up period
- Current enrollment in an HIV prevention trial
- Current or past participation in an HIV vaccine trial
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of the overall HIV-1 incidence rate among 2,000 women in the US from defined geographic areas with high HIV prevalence and poverty
Time frame: Throughout study
6 secondary outcomes
Evaluation of laboratory assays for HIV-1 incidence determination
Time frame: Throughout study
Estimation of recruitment and retention rates
Time frame: Throughout study
Assessment of women's preferred recruitment and retention strategies for future studies
Time frame: Throughout study
Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies
Time frame: Throughout study
Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive
Time frame: Throughout study
Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies
Time frame: Throughout study
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 30 Aug 2022.
- Background: PubMed 21406990Hodder SL, Justman J, Haley DF, Adimora AA, Fogel CI, Golin CE, O'Leary A, Soto-Torres L, Wingood G, El-Sadr WM; HIV Prevention Trials Network Domestic Prevention in Women Working Group. Challenges of a hidden epidemic: HIV prevention among women in the United States. J Acquir Immune Defic Syndr. 2010 Dec;55 Suppl 2(Suppl 2):S69-73. doi: 10.1097/QAI.0b013e3181fbbdf9.
- Background: PubMed 24007379Haley DF, Justman JE. The HIV epidemic among women in the United States: a persistent puzzle. J Womens Health (Larchmt). 2013 Sep;22(9):715-7. doi: 10.1089/jwh.2013.4562. No abstract available.
- Background: PubMed 24697160Haley DF, Lucas J, Golin CE, Wang J, Hughes JP, Emel L, El-Sadr W, Frew PM, Justman J, Adimora AA, Watson CC, Mannheimer S, Rompalo A, Soto-Torres L, Tims-Cook Z, Carter Y, Hodder SL; HPTN 064 Study Team. Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064). AIDS Patient Care STDS. 2014 Apr;28(4):206-17. doi: 10.1089/apc.2013.0366.
- Results publication: PubMed 23129758Eshleman SH, Hughes JP, Laeyendecker O, Wang J, Brookmeyer R, Johnson-Lewis L, Mullis CE, Hackett J Jr, Vallari AS, Justman J, Hodder S. Use of a multifaceted approach to analyze HIV incidence in a cohort study of women in the United States: HIV Prevention Trials Network 064 Study. J Infect Dis. 2013 Jan 15;207(2):223-31. doi: 10.1093/infdis/jis658. Epub 2012 Nov 5.
- Results publication: PubMed 23277896Hodder SL, Justman J, Hughes JP, Wang J, Haley DF, Adimora AA, Del Rio C, Golin CE, Kuo I, Rompalo A, Soto-Torres L, Mannheimer SB, Johnson-Lewis L, Eshleman SH, El-Sadr WM; HIV Prevention Trials Network 064; Women's HIV SeroIncidence Study Team. HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med. 2013 Jan 1;158(1):10-8. doi: 10.7326/0003-4819-158-1-201301010-00004.
- Results publication: PubMed 24056163Adimora AA, Hughes JP, Wang J, Haley DF, Golin CE, Magnus M, Rompalo A, Justman J, del Rio C, El-Sadr W, Mannheimer S, Soto-Torres L, Hodder SL; HPTN 064 Protocol Team. Characteristics of multiple and concurrent partnerships among women at high risk for HIV infection. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):99-106. doi: 10.1097/QAI.0b013e3182a9c22a.
- Results publication: PubMed 24742266Haley DF, Golin C, El-Sadr W, Hughes JP, Wang J, Roman Isler M, Mannheimer S, Kuo I, Lucas J, DiNenno E, Justman J, Frew PM, Emel L, Rompalo A, Polk S, Adimora AA, Rodriquez L, Soto-Torres L, Hodder S. Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt). 2014 Jun;23(6):541-51. doi: 10.1089/jwh.2013.4654. Epub 2014 Apr 17.
- Results publication: PubMed 24698079Kuo I, Golin CE, Wang J, Haley DF, Hughes J, Mannheimer S, Justman J, Rompalo A, Frew PM, Adimora AA, Soto-Torres L, Hodder S; HPTN 064 Study Team. Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend. 2014 Jun 1;139:93-9. doi: 10.1016/j.drugalcdep.2014.03.007. Epub 2014 Mar 19.
- Derived from this study: PubMed 32883248Abrams JA, Odlum M, Tillett E, Haley D, Justman J, Hodder S, Vo L, O'Leary A, Frew PM; HIV Prevention Trials Network 064 (HTPN) Study Team. Strategies for increasing impact, engagement, and accessibility in HIV prevention programs: suggestions from women in urban high HIV burden counties in the Eastern United States (HPTN 064). BMC Public Health. 2020 Sep 3;20(1):1340. doi: 10.1186/s12889-020-09426-6.
- Derived from this study: PubMed 27530401Frew PM, Parker K, Vo L, Haley D, O'Leary A, Diallo DD, Golin CE, Kuo I, Soto-Torres L, Wang J, Adimora AA, Randall LA, Del Rio C, Hodder S; HIV Prevention Trials Network 064 (HTPN) Study Team. Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064). BMC Public Health. 2016 Aug 17;16(1):803. doi: 10.1186/s12889-016-3364-7.
- Individual participant dataSharing planned: No. Data was collated into manuscripts by the statistical and data management center for the HPTN.
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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.
Sally Hodder, MD study chair
UMDNJ - New Jersey Medical School
Jessica Justman study chair
Columbia University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by HIV Prevention Trials Network at 9 sites 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 25 inclusion and 6 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Estimation of the overall HIV-1 incidence rate among 2,000 women in the US from defined geographic areas with high HIV prevalence and poverty (time frame: Throughout study). 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 NCT00995176, which also lists 10 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 30 Aug 2022.