A Combination HIV Prevention Strategy for Young Women at Risk for HIV

Human Immunodeficiency Virus Clinical Trial

— IPrEP  

Official title:

A Combination HIV Prevention Strategy for Young Women at Risk for HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235518
• Other study ID #: AAAR0256
• Secondary ID: R01MH110051
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: April 4, 2018

Study information

• Verified date: January 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Kenya.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: April 4, 2018
• Est. primary completion date: March 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Locations

Country	Name	City	State
Kenya	Kisumu, Kenya	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months