HIV InfectionsNCT00872261
Determining Characteristics and Behaviors of Adolescent Women Regarding HIV Risk and Microbicide Trial Participation
An observational study of HIV Infections, run by FHI 360 at 1 site in Tanzania.
Trial summary
This study will examine characteristics and behaviors of young women in India and Tanzania to determine which challenges and opportunities exist for conducting future trials of HIV prevention treatments. Read more about this study
- Who is it for?
- Ages 15 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 135 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2010to Jan 2013
- 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 15 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Formative research will recruit adolescents and other participants from community samples in Pune, India and Dar es Salaam, Tanzania. Pilot clinical study will recruit adolescents from India and Tanzania through healthcare facilities, nongovernmental organizations, and other mechanisms.
Who may be able to join
- Sexually active in the 3 months prior to screening
- Willing to provide biological samples and answer questions about sexual behaviors
Who cannot join
- Pregnancy
- HIV infected
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Adolescent Women & Microbicide Trials: Assessing the Challenges & Opportunities to Their Participation
This study will examine characteristics and behaviors of young women in India and Tanzania to determine which challenges and opportunities exist for conducting future trials of HIV prevention treatments.
Read the detailed description
HIV is an infection that damages a person's immune system and can develop into AIDS. More than 10 million women between the ages of 15 and 24 currently live with HIV or AIDS, most of them in sub-Saharan Africa and Asia. The rate of infections in women is high in part because they may not be able to use existing HIV prevention methods: remaining abstinent does not help if their partner is not also abstinent and using a male condom requires the compliance of the male. Oral and topical microbicides are products women initiate using to reduce their risk of HIV infection. Several clinical trials of these products have been conducted, but few have tested populations of young women, who may have different characteristics or behaviors from other women. This study will collect data on the characteristics and behaviors of women divided into two age groups, women age 15 to 17 and women age 18 to 21, in both Tanzania and India. This study will have four goals: (1) to determine whether and how characteristics that put women at risk for HIV differ in these age and country groups; (2) to evaluate the legal, social, cultural, and delivery factors that hinder women's participation in microbicide trials; (3) to examine the understanding and ability of women in these different groups to adhere to the requirements of clinical trial participation; and (4) to determine young women's acceptability and use of a practice gel or pill.
This study will consist of three phases. The first phase will address the first two goals by conducting repeated, in-depth interviews and discussions with a small group of sexually active adolescents in India and Tanzania, followed up by interviews with informants and relevant community members. These interviews and discussions will address differences in HIV risk characteristics between groups of women and the legal, social, cultural, and delivery factors hindering women's participation in microbicide trials. The second phase will consist of a series of workshops to define and describe a set of youth-friendly procedures for using microbicides. Community members and researchers will participate in these workshops, and some adolescents will be invited to pretest the study instruments.
The third phase will be a pilot clinical study that addresses the second two goals by asking participants to undergo evaluations over time, similar to the way they would have to in a microbicide trial. Participants will complete study visits at baseline and after 2, 4, and 6 months, during which time they will answer questions about their sexual relationships and use of risk reduction behaviors. They will also provide urine, blood, and endo-cervical swab samples for testing for pregnancy, HIV, and sexually transmitted infection. Between the 4- and 6-month visits, participants will also be asked to participate in a 2-month substudy in which they use proxy pills or gels. They will then complete interviews about their experiences using the pills or gels. Some participants who decline to participate will be invited to complete brief interviews about why they chose not to participate.
- Conditions
- HIV Infections
- Keywords
- Clinical Trials as Topic, Adolescent Psychology, Patient Acceptance of Health Care, HIV Risk Behaviors, Adolescents, Clinical Trial Recruitment, Microbicide Acceptability, Ethics, Mixed Methods, HIV
- Medical subject headings
- HIV Infections, Patient Acceptance of Health Care
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 |
|---|---|---|
| Proxy microbicide product | Use of vaginal lubricant as a proxy microbicide gel; use of multivitamin as proxy pre-exposure prophylaxis (PrEP) product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of sexually transmitted infections, such as chlamydia, gonorrhea, genital herpes, or HIV
Measured: Measured at baseline and after 4 months
Adherence to condom use
Measured: Measured over 6 months
Reasons for nonparticipation in clinical study
Measured: Measured at screening
Retention, defined as the proportion of follow-up visits during the measurement window
Measured: Measured over 6 months
Proportion of participants recruited into the microbicide substudy
Measured: Measured over 2 months
Secondary outcomes (1)
Description of sexual risk patterns and psychosocial mediators of risk
Measured: Measured during formative research and during the 6-month pilot clinical study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth E. Tolley, PhD, Principal investigator, FHI 360Sylvia Kaaya, PhD, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872261
- Sponsor's protocol ID
- R01MH086160
- Other IDs
- R01MH086160, DAHBR 9A-ASPA, Tolley 1 R01 MH086160-01
- Status last verified
- Apr 2013
- First submitted
- 30 Mar 2009
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tolley EE, Kaaya S, Kaale A, Minja A, Bangapi D, Kalungura H, Headley J, Baumgartner JN. Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials. J Int AIDS Soc. 2014 Sep 8;17(3 Suppl 2):19149. doi: 10.7448/IAS.17.3.19149. eCollection 2014.
PubMed 25224611
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Women & Microbicide Trials: Assessing the Challenges & Opportunities to Their Participation
- ClinicalTrials.gov ID
- NCT00872261
- Acronym / sponsor ID
- R01MH086160
- Conditions
- HIV Infections
- Keywords
- Clinical Trials as Topic, Adolescent Psychology, Patient Acceptance of Health Care, HIV Risk Behaviors, Adolescents, Clinical Trial Recruitment, Microbicide Acceptability, Ethics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Mar 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.
This study will examine characteristics and behaviors of young women in India and Tanzania to determine which challenges and opportunities exist for conducting future trials of HIV prevention treatments.
Detailed description
HIV is an infection that damages a person's immune system and can develop into AIDS. More than 10 million women between the ages of 15 and 24 currently live with HIV or AIDS, most of them in sub-Saharan Africa and Asia. The rate of infections in women is high in part because they may not be able to use existing HIV prevention methods: remaining abstinent does not help if their partner is not also abstinent and using a male condom requires the compliance of the male. Oral and topical microbicides are products women initiate using to reduce their risk of HIV infection. Several clinical trials of these products have been conducted, but few have tested populations of young women, who may have different characteristics or behaviors from other women. This study will collect data on the characteristics and behaviors of women divided into two age groups, women age 15 to 17 and women age 18 to 21, in both Tanzania and India. This study will have four goals: (1) to determine whether and how characteristics that put women at risk for HIV differ in these age and country groups; (2) to evaluate the legal, social, cultural, and delivery factors that hinder women's participation in microbicide trials; (3) to examine the understanding and ability of women in these different groups to adhere to the requirements of clinical trial participation; and (4) to determine young women's acceptability and use of a practice gel or pill.
This study will consist of three phases. The first phase will address the first two goals by conducting repeated, in-depth interviews and discussions with a small group of sexually active adolescents in India and Tanzania, followed up by interviews with informants and relevant community members. These interviews and discussions will address differences in HIV risk characteristics between groups of women and the legal, social, cultural, and delivery factors hindering women's participation in microbicide trials. The second phase will consist of a series of workshops to define and describe a set of youth-friendly procedures for using microbicides. Community members and researchers will participate in these workshops, and some adolescents will be invited to pretest the study instruments.
The third phase will be a pilot clinical study that addresses the second two goals by asking participants to undergo evaluations over time, similar to the way they would have to in a microbicide trial. Participants will complete study visits at baseline and after 2, 4, and 6 months, during which time they will answer questions about their sexual relationships and use of risk reduction behaviors. They will also provide urine, blood, and endo-cervical swab samples for testing for pregnancy, HIV, and sexually transmitted infection. Between the 4- and 6-month visits, participants will also be asked to participate in a 2-month substudy in which they use proxy pills or gels. They will then complete interviews about their experiences using the pills or gels. Some participants who decline to participate will be invited to complete brief interviews about why they chose not to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proxy microbicide product | – | –Use of vaginal lubricant as a proxy microbicide gel; use of multivitamin as proxy pre-exposure prophylaxis (PrEP) product |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Formative research will recruit adolescents and other participants from community samples in Pune, India and Dar es Salaam, Tanzania. Pilot clinical study will recruit adolescents from India and Tanzania through healthcare facilities, nongovernmental organizations, and other mechanisms.
Key inclusion criteria (2 listed)
- Sexually active in the 3 months prior to screening
- Willing to provide biological samples and answer questions about sexual behaviors
Key exclusion criteria (2 listed)
- Pregnancy
- HIV infected
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
Presence of sexually transmitted infections, such as chlamydia, gonorrhea, genital herpes, or HIV
Time frame: Measured at baseline and after 4 months
Adherence to condom use
Time frame: Measured over 6 months
Reasons for nonparticipation in clinical study
Time frame: Measured at screening
Retention, defined as the proportion of follow-up visits during the measurement window
Time frame: Measured over 6 months
Proportion of participants recruited into the microbicide substudy
Time frame: Measured over 2 months
1 secondary outcome
Description of sexual risk patterns and psychosocial mediators of risk
Time frame: Measured during formative research and during the 6-month pilot clinical 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 1 May 2013.
- Derived from this study: PubMed 25224611Tolley EE, Kaaya S, Kaale A, Minja A, Bangapi D, Kalungura H, Headley J, Baumgartner JN. Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials. J Int AIDS Soc. 2014 Sep 8;17(3 Suppl 2):19149. doi: 10.7448/IAS.17.3.19149. eCollection 2014.
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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.
Elizabeth E. Tolley, PhD principal investigator
FHI 360
Sylvia Kaaya, PhD principal investigator
Muhimbili University of Health and Allied Sciences
1 site 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 FHI 360 at 1 site in Tanzania.
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 2 inclusion and 2 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 1 May 2013. 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 Tanzania. 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?
Presence of sexually transmitted infections, such as chlamydia, gonorrhea, genital herpes, or HIV (time frame: Measured at baseline and after 4 months). The study lists 5 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 NCT00872261, which also lists 1 linked publication.
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 1 May 2013.