Human Immunodeficiency Virus Clinical Trial
Official title:
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
Verified date | January 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.
Status | Active, not recruiting |
Enrollment | 1500 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Male - Age 18-39 years - Resides in study community and plans to remain for the next 2 years - Used alcohol or other substances in the past month - Engagement in any transactional sex (defined as payment of money, goods, or services in exchange for sex) in the past 3 months - Has a steady income source that typically results in earnings every week - Owns mobile phone - Already has or is willing to open an account with partner banking institution - Has national identification card (required for opening bank account) - Has Kenya Revenue Authority personal identification number or is willing to create one (required for opening bank account) Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Kenya | Impact Research and Development Organization | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Impact Research & Development Organization, RTI International, University of California, San Francisco, University of Washington |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of HIV and other STIs | Composite incidence of at least one of HIV or other STIs (herpes simplex virus type 2 (HSV-2), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT)) over 24 months. The investigators will combine all STIs (including HIV) into a composite variable, with each participant counting once. For participants who are HIV-positive at baseline or HSV-2-positive, the outcome will be defined over all STIs other than HIV. | 24 months | |
Secondary | Expenditures on alcohol | Money spent on alcohol. | 6 month intervals | |
Secondary | Expenditures on transactional sex | Money, goods, and services spent on transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners). | 6 month intervals | |
Secondary | Expenditures on gambling | Money spent on gambling. | 6 month intervals | |
Secondary | Number of sexual partners | Number of sexual partners participant had in the past 3 months. | 6 month intervals | |
Secondary | Recent engagement in transactional sex | Whether participant engaged in transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners), or not in the past 3 months. | 6 month intervals | |
Secondary | Number of transactional sex partners | Total number of transactional sex partners participant had in the past 3 months. | 6 month intervals | |
Secondary | Number of transactional sex encounters | Number of transactional sex encounters participant engaged in during the past 3 months. | 6 month intervals | |
Secondary | Condom use at most recent sexual encounter | Whether participant used a condom or not at most recent sexual encounter in the past 3 months. | 6 month intervals | |
Secondary | Alcohol use | As measured by the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) scale. The AUDIT-C is scored on a scale of 0-12, and higher values mean worse outcomes | 6 month intervals | |
Secondary | HIV, CT, and NG incidence between 0-12 months and 12-24 months | More temporally granular measures of incidence for HIV, CT, and NG. | Up to 24 months | |
Secondary | Engagement in care among those who are HIV-positive | Whether or not participants who are HIV-positive are currently engaged in care for their HIV. | 6 month intervals | |
Secondary | Expenditures on food | Money spent on food items. | 6 month intervals | |
Secondary | Expenditures on household needs | Money spent on household needs (e.g., utilities). | 6 month intervals | |
Secondary | Savings and investment | Total savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital. | 6 month intervals | |
Secondary | Total formal savings | The sum of savings balances in all formal bank accounts. | 6 month intervals | |
Secondary | Total household assets | Value of all assets. | 6 month intervals | |
Secondary | Expenditure on human capital investment | Money spent on human capital investment (e.g., spending on children's education). | 6 month intervals | |
Secondary | Expenditure on productive assets | Money spent on productive assets (e.g., spending on agricultural equipment). | 6 month intervals | |
Secondary | Expenditure on housing improvement | Money spent on structure of dwelling. | 6 month intervals |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03516318 -
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
|
N/A | |
Completed |
NCT04653194 -
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
|
Phase 3 | |
Completed |
NCT01792570 -
DRV/r + RPV QD: Efficacy and Toxicity Reduction
|
Phase 3 | |
Active, not recruiting |
NCT04826562 -
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
|
Phase 4 | |
Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
Completed |
NCT02812329 -
Intervention to Encourage HIV Testing and Counseling Among Adolescents
|
Phase 1 | |
Completed |
NCT02919306 -
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
|
Phase 1/Phase 2 | |
Completed |
NCT02651376 -
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
Completed |
NCT01944371 -
Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT01778374 -
Mater-Bronx Rapid HIV Testing Project.
|
N/A | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT01076179 -
Kaletra in Combination With Antiretroviral Agents
|
N/A | |
Completed |
NCT01490346 -
Tissue Drug Levels of HIV Medications
|
N/A | |
Completed |
NCT01460433 -
Problems With Immune Recovery in the Gut Tissue
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Terminated |
NCT04240210 -
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
|
Phase 4 | |
Active, not recruiting |
NCT04704336 -
Integration of Hypertension Management Into HIV Care in Nigeria
|
N/A | |
Completed |
NCT03254277 -
3BNC117-LS First-in-Human Phase 1 Study
|
Phase 1 |