Human Immunodeficiency VirusIPrEPNCT03235518
A Combination HIV Prevention Strategy for Young Women at Risk for HIV
An observational study of Human Immunodeficiency Virus, run by Columbia University at 1 site in Kenya.
Trial summary
The purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 329 participants
- Where
- 1 siteKenya
- Study dates
- 28 Jun 2017to 4 Apr 2018
- 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
- Adult, Older adult
Study population: Female sex workers, male clients of female sex workers, and health care providers will be enrolled.
Who may be able to join
- FSW. Inclusion criteria for the structured interviews, FGDs and IDI are identical.
- Report being female or transgender women born make who have sex with men
- Report being HIV-negative or unknown status
- Report being between 18-24 years of age
- Report residing or working in study community
- Reports exchange sex for goods, money, flavors or other services in past 3 months
Show all 19Show fewer
- Willing to allow audio-recording of FGDs or IDI
- Able to complete study procedures in English, Kiswahili or Dhuluo
- Male Clients
- Male
- Report being >=18 years of age
- Report exchanging goods, money, favors or other services for sex in past 3 months
- Willing to allow audio-recording of IDI
- Able to complete study procedures in English, Kiswahili or Dhuluo
- Health Care Providers
- Currently working as nurse or clinical officer at a clinic or other facility likely to offer PrEP
- Report being >= 18 years of age
- Willing to allow audio-recording of IDI
- Able to complete study procedures in English
Who cannot join
- Individuals who do not meet the inclusion criteria
- Individuals who in the opinion of the investigators would interfere with adherence to study study requirements
- FSW participating in FGD are not eligible for participation in IDI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in Kenya.
Read the detailed description
Despite remarkable advances in the global HIV response with 17 million persons, out of nearly 37 million living with HIV, who have initiated antiretroviral therapy (ART) in low- and middle-income countries (LMIC) as of end of 2015, there were an estimated 5,700 new HIV infections each day and a total of 2.1 million new HIV infections in 2015, of which 66% were in sub-Saharan Africa (SSA). Key populations within the generalized HIV epidemics in SSA, including female sex workers (FSW), have received insufficient attention, with data indicating that they are at disproportionate risk with limited access to prevention and treatment services. Globally, new infections among key populations and their sexual partners accounted for 36% of all new HIV infections in 2015. HIV prevalence among FSW is 29.3% worldwide. While reliable HIV prevalence estimates are lacking, younger FSW <25 years may be at significantly greater risk due to the confluence of biological, behavioral and structural risk factors.6 Mathematical modeling suggests that the proportion of new HIV infections attributable to sex work is likely to increase over time.
In settings where key populations contribute substantially to HIV burden, as in Kenya, effective integrated prevention strategies are urgently needed for populations such as FSW and can have a substantial impact on reducing new HIV infections.
In 2012, HIV prevalence among Kenyan 15-64 year olds was 5.6%, with 1,192,000 people living with HIV, but was markedly higher (15.1%) in the region of Kenya, formerly named Nyanza Province. HIV prevalence is 14.1% among FSW and 7.6% among male clients of sex workers (MC). FSW contribute significantly to new HIV infections in Kenya,14 with modelled estimates showing that 1 in 3 new HIV infections can be attributed to key populations.
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV Prevention, Female sex workers
- Medical subject headings
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| Structure Interviews with FSW | Structured interviews with 200 purposively sampled FSW will be conducted. These interviews will be conducted prior to focus group discussion (FGD) and in-depth qualitative interview (IDI) with FSW. Structured interviews will take approximately 45-60 minutes to complete and will be administered privately in Kiswahili, Dholuo or English by trained female research staff. Quantitative interviews will be administered to conduct an assessment of FSW sociodemographics, sexual behaviour patterns and HIV-related knowledge, attitudes and practices regarding HIV prevention and other factors that might affect initiation and adherence to PrEP use, ability to use PrEP covertly, HIV testing history, mobility patterns, social networks, pregnancy intentions, ability to use condoms consistently with clients, and regular partners, and interpersonal violence from clients, regular partners and the police. | |
| Focus Group Discussions with FSW | Three to five FGDs of up to 10 FSW per group will be conducted. These FGD will take place prior to FSW IDI. FSW who participated in FGDs will be ineligible for participation in the IDI. All group discussions will last approximately 1.5 to 2 hours and be conducted in Kiswahili, Dholuo or English. Each group discussion will be facilitated by trained female research staff and held in a private space at a pre-specified location. The themes that will be explored in the FGDs include: FSW social networks, participation in PrEP studies, barriers and facilitators to PrEP use and use of resource transfers for PrEP adherence. In addition, participants will complete a brief demographic survey. | |
| In-Depth Qualitative Interviews with FSW | 30 IDI will be conducted with FSW. FSW who participated in FGDs will be ineligible for participation in the IDI. All in-depth interviews will be conducted by trained female research staff using a semi-structured interview guide. All interviews will be held in a private space at a pre-specified location within the community. The topics that will be discussed in the IDI with FSW include demographics, social support, dynamics of sex work, HIV prevention methods (including condom use), perception of HIV risk and development of PrEP intervention. | |
| In-Depth Qualitative Interviews with MC | 30 IDI will be conducted with MC. All IDI will last approximately 60-90 minutes and be conducted in Kiswahili, Dholuo, or English. Each interview will be conducted by a trained male research staff using semi-structured interview guide. All interviews will be held in a private space at a pre-specified location. Topics include demographics, relationships with FSW, HIV prevention methods (including use of condoms), perception of HIV risk and development of PrEP intervention. | |
| In-Depth Qualitative Interviews with HCPs | 30 IDI will be conducted with health care provider (HCP). All IDI will last approximately 60-90 minutes and be conducted in English. Each interview will be conducted by trained research staff using a semi-structured interview guide. Interviews will be held in a private space at the health facility where they work or another venue preferred by the HCP. Topics include demographics, health care needs of FSW and sources of care, HIV prevention needs of FSW, PrEP for FSW and training needs for HCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of FSW participants who would be willing to participate in HIV prevention research
To inform prevention interventions for FSW, we will assess the percentage of FSW willing to participate in HIV prevention research or a PrEP study
Measured: 6 months
Secondary outcomes (1)
Percentage of MC participants who would be willing to participate in HIV prevention research
To inform prevention interventions, we will assess the percentage of MC willing to participate in HIV prevention research
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start28 Jun 2017
- Primary completion30 Mar 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Wafaa M. El-Sadr, MD, MPH, MPA, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235518
- Sponsor's protocol ID
- AAAR0256
- Other IDs
- R01MH110051
- Acronym
- IPrEP
- Status last verified
- Jan 2022
- First submitted
- 28 Jul 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination HIV Prevention Strategy for Young Women at Risk for HIV
- ClinicalTrials.gov ID
- NCT03235518
- Acronym / sponsor ID
- IPrEP / AAAR0256
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV Prevention, Female sex workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 1 Aug 2017 (actual)
- 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 purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in Kenya.
Detailed description
Despite remarkable advances in the global HIV response with 17 million persons, out of nearly 37 million living with HIV, who have initiated antiretroviral therapy (ART) in low- and middle-income countries (LMIC) as of end of 2015, there were an estimated 5,700 new HIV infections each day and a total of 2.1 million new HIV infections in 2015, of which 66% were in sub-Saharan Africa (SSA). Key populations within the generalized HIV epidemics in SSA, including female sex workers (FSW), have received insufficient attention, with data indicating that they are at disproportionate risk with limited access to prevention and treatment services. Globally, new infections among key populations and their sexual partners accounted for 36% of all new HIV infections in 2015. HIV prevalence among FSW is 29.3% worldwide. While reliable HIV prevalence estimates are lacking, younger FSW <25 years may be at significantly greater risk due to the confluence of biological, behavioral and structural risk factors.6 Mathematical modeling suggests that the proportion of new HIV infections attributable to sex work is likely to increase over time.
In settings where key populations contribute substantially to HIV burden, as in Kenya, effective integrated prevention strategies are urgently needed for populations such as FSW and can have a substantial impact on reducing new HIV infections.
In 2012, HIV prevalence among Kenyan 15-64 year olds was 5.6%, with 1,192,000 people living with HIV, but was markedly higher (15.1%) in the region of Kenya, formerly named Nyanza Province. HIV prevalence is 14.1% among FSW and 7.6% among male clients of sex workers (MC). FSW contribute significantly to new HIV infections in Kenya,14 with modelled estimates showing that 1 in 3 new HIV infections can be attributed to key populations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Structure Interviews with FSW | – | –Structured interviews with 200 purposively sampled FSW will be conducted. These interviews will be conducted prior to focus group discussion (FGD) and in-depth qualitative interview (IDI) with FSW. Structured interviews will take approximately 45-60 minutes to complete and will be administered privately in Kiswahili, Dholuo or English by trained female research staff. Quantitative interviews will be administered to conduct an assessment of FSW sociodemographics, sexual behaviour patterns and HIV-related knowledge, attitudes and practices regarding HIV prevention and other factors that might affect initiation and adherence to PrEP use, ability to use PrEP covertly, HIV testing history, mobility patterns, social networks, pregnancy intentions, ability to use condoms consistently with clients, and regular partners, and interpersonal violence from clients, regular partners and the police. |
| Focus Group Discussions with FSW | – | –Three to five FGDs of up to 10 FSW per group will be conducted. These FGD will take place prior to FSW IDI. FSW who participated in FGDs will be ineligible for participation in the IDI. All group discussions will last approximately 1.5 to 2 hours and be conducted in Kiswahili, Dholuo or English. Each group discussion will be facilitated by trained female research staff and held in a private space at a pre-specified location. The themes that will be explored in the FGDs include: FSW social networks, participation in PrEP studies, barriers and facilitators to PrEP use and use of resource transfers for PrEP adherence. In addition, participants will complete a brief demographic survey. |
| In-Depth Qualitative Interviews with FSW | – | –30 IDI will be conducted with FSW. FSW who participated in FGDs will be ineligible for participation in the IDI. All in-depth interviews will be conducted by trained female research staff using a semi-structured interview guide. All interviews will be held in a private space at a pre-specified location within the community. The topics that will be discussed in the IDI with FSW include demographics, social support, dynamics of sex work, HIV prevention methods (including condom use), perception of HIV risk and development of PrEP intervention. |
| In-Depth Qualitative Interviews with MC | – | –30 IDI will be conducted with MC. All IDI will last approximately 60-90 minutes and be conducted in Kiswahili, Dholuo, or English. Each interview will be conducted by a trained male research staff using semi-structured interview guide. All interviews will be held in a private space at a pre-specified location. Topics include demographics, relationships with FSW, HIV prevention methods (including use of condoms), perception of HIV risk and development of PrEP intervention. |
| In-Depth Qualitative Interviews with HCPs | – | –30 IDI will be conducted with health care provider (HCP). All IDI will last approximately 60-90 minutes and be conducted in English. Each interview will be conducted by trained research staff using a semi-structured interview guide. Interviews will be held in a private space at the health facility where they work or another venue preferred by the HCP. Topics include demographics, health care needs of FSW and sources of care, HIV prevention needs of FSW, PrEP for FSW and training needs for HCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Female sex workers, male clients of female sex workers, and health care providers will be enrolled.
Key inclusion criteria (19 listed)
- FSW. Inclusion criteria for the structured interviews, FGDs and IDI are identical.
- Report being female or transgender women born make who have sex with men
- Report being HIV-negative or unknown status
- Report being between 18-24 years of age
- Report residing or working in study community
Key exclusion criteria (3 listed)
- Individuals who do not meet the inclusion criteria
- Individuals who in the opinion of the investigators would interfere with adherence to study study requirements
- FSW participating in FGD are not eligible for participation in IDI
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
Percentage of FSW participants who would be willing to participate in HIV prevention research
Time frame: 6 months
To inform prevention interventions for FSW, we will assess the percentage of FSW willing to participate in HIV prevention research or a PrEP study
1 secondary outcome
Percentage of MC participants who would be willing to participate in HIV prevention research
Time frame: 6 months
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 10 Jan 2022.
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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.
Wafaa M. El-Sadr, MD, MPH, MPA 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?
An observational study of Human Immunodeficiency Virus, run by Columbia University at 1 site in Kenya.
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 19 inclusion and 3 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 10 Jan 2022. 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 Kenya. 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?
Percentage of FSW participants who would be willing to participate in HIV prevention research (time frame: 6 months). 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 10 Jan 2022.