Microeconomic Intervention for HIV Prevention

(Secure Trial)

Overseen By Kristi E Gamarel, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Non-transgender, Non-person of color, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new program, SeCuRE, can enhance HIV prevention and care among transgender women of color. Participants will divide into two groups: one will receive immediate access to support, including cash grants, legal help, and job postings, while the other will receive usual care and access to the program later. The trial seeks transgender women of color living in the Detroit area who earn less than $32,800 a year and have had condomless sex in the past six months. As an unphased trial, this study offers a unique opportunity to access potentially life-changing support and resources early.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SeCuRE intervention is safe for transgender women of color?

Research has shown that programs aimed at improving financial stability can help prevent HIV. Although specific safety details for the SeCuRE program are not available, similar programs typically offer support such as cash assistance and mentoring. These services are generally well-received because they aim to enhance financial and social well-being.

The SeCuRE program provides financial help and community mentoring. These activities are not known to cause physical harm, suggesting that the program is likely safe for participants. However, discussing any concerns with the trial team or a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SeCuRE intervention for HIV prevention because it takes a holistic approach, addressing both economic and social factors. Unlike standard HIV prevention methods, which often focus solely on medical prevention like PrEP or condom distribution, SeCuRE combines a one-time emergency cash grant with ongoing educational sessions and community mentoring. This intervention also empowers participants by supporting legal gender affirmation and providing resources to pursue employment opportunities. By tackling the root causes of vulnerability to HIV, such as economic instability and social marginalization, this approach has the potential to create lasting change in participants' lives beyond just preventing HIV.

What evidence suggests that the SeCuRE intervention could be effective for HIV prevention?

Research shows that preventive measures can lower the risk of sexually transmitted infections (STIs) by 41%. This trial will evaluate the SeCuRE intervention, designed to significantly help prevent HIV. Participants in the Immediate Intervention arm will receive comprehensive support, including financial assistance and educational resources. Studies on similar programs have shown positive results, such as fewer new HIV cases and more frequent condom use. By offering financial support and educational resources, interventions like SeCuRE can strengthen efforts to prevent HIV. Additionally, investing in prevention strategies has saved on medical costs over time. Programs supporting HIV prevention can be both effective for health and cost-saving. ^{3 4 6 7 8}

Who Is on the Research Team?

Kristi Gamarel, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for transgender women of color. It's a small study to see if the SeCuRE intervention can help with HIV prevention and care. Participants will be split into two groups, one getting the intervention right away and the other later.

Inclusion Criteria

Self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white)

Lives in Detroit, MI greater metropolitan area (~50 mile radius)

I was assigned male at birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week microeconomic intervention including educational sessions, mentoring, and a micro-grant

12 weeks

12 weekly sessions (in-person)

Follow-up

Participants complete a follow-up survey immediately after intervention and a 3-month survey post-intervention

3 months

Qualitative Exit Interviews

Participants complete qualitative exit interviews within one month of intervention completion

1 month

What Are the Treatments Tested in This Trial?

Interventions

• SeCuRE intervention

Trial Overview The SeCuRE intervention is being tested in this pilot randomized controlled trial (RCT). The goal is to check if it's feasible and acceptable for improving HIV-related outcomes among participants.

How Is the Trial Designed?

Group I: Immediate Intervention Experimental Treatment 1 Intervention

The intervention condition builds on our community partners' existing microeconomic intervention of: (1) a one-time emergency cash grant and (2) peer and legal support to obtain legal gender affirmation - plus a 12-week microeconomic intervention that adds: (3) weekly educational sessions and HIV prevention; (4) community mentoring; and (5) weekly posts of job openings in Detroit; and (6) a micro-grant for use towards acquiring self-led or formal employment

Group II: Delayed Arm Active Control 1 Intervention

Participants randomized to the control condition will receive UC during the 12-week period following randomization. Usual care consists of emergency assistance and access to legal name/gender marker change. After the RCT follow-up period is complete, waitlist control participants will be offered delayed access to the same intervention that is provided immediately to intervention arm participants.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study involved 96 AIDS-orphaned adolescents in Uganda, who were randomly assigned to either an economic intervention or usual care, highlighting a targeted approach to HIV risk reduction.

After 12 months, the adolescents who received the intervention showed significant improvements in their attitudes towards HIV prevention and educational planning compared to those who received standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel economic intervention to reduce HIV risks among school-going AIDS orphans in rural Uganda. Ssewamala, FM., Alicea, S., Bannon, WM., et al.[2018]

The cost analysis of an HIV-prevention intervention showed that it costs approximately $50,306.40 per year to serve 150 clients, translating to about $335.38 per client.

To be considered cost-saving, the intervention must prevent at least 0.411 HIV infections among the 150 clients, highlighting the importance of effectiveness in economic evaluations for service providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disseminating effective behavioral interventions for HIV prevention: a cost analysis of a risk-reduction intervention for drug users. Trentacoste, ND., Holtgrave, DR., Collins, C., et al.[2019]

The study aims to reduce HIV infections among women aged 15 to 29 in Botswana, Namibia, and Swaziland through a combination of interventions targeting choice disability, gender violence, and self-esteem, involving a random sample of 77 census areas.

The effectiveness of these interventions will be evaluated after 3 years using surveys to measure HIV infection rates and changes in knowledge, attitudes, and practices related to HIV and gender violence among youth, with a focus on those who may struggle to make prevention choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial. Andersson, N., Cockcroft, A., Thabane, L., et al.[2022]

Research shows that wealthier countries and individuals in sub-Saharan Africa are at a higher risk for HIV infection, challenging the common belief that poverty drives the epidemic.

The article suggests that economic and social policies should be used as structural interventions to prevent HIV, highlighting the need to rethink traditional behavioral approaches in light of the positive-wealth gradient observed in HIV infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The social determinants of HIV serostatus in sub-Saharan Africa: an inverse relationship between poverty and HIV? Fox, AM.[2022]

The study established a monetary threshold of $417,000 per HIV infection averted for evaluating the cost-effectiveness of HIV prevention programs, with variations ranging from $185,000 to $648,000 based on societal willingness to pay for quality-adjusted life years.

This threshold can help guide economic evaluations of HIV prevention activities, allowing policymakers to assess whether specific programs are cost-effective and warrant further investment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Threshold analysis and programs for prevention of HIV infection. Holtgrave, DR., Qualls, NL.[2019]

Mathematical models are essential for estimating the effectiveness of HIV prevention programs, as direct measurement of effectiveness through changes in HIV incidence is often not feasible.

The cost-effectiveness of these programs is influenced by community risk levels and the behavioral changes achieved through the interventions, highlighting the importance of understanding both costs and behavioral impacts in HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling cost-effectiveness of HIV prevention programs. Johnson-Masotti, AP.[2009]

Conditional economic incentives (CEIs) have been shown to effectively increase HIV testing rates and voluntary male circumcision in low- and middle-income countries, leading to improved short-term HIV prevention and treatment outcomes.

There is a need for further research to understand the mechanisms behind the long-term effectiveness of these incentives and to develop strategies that address the biases and constraints affecting health-related decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditional economic incentives to improve HIV prevention and treatment in low-income and middle-income countries. Galárraga, O., Sosa-Rubí, SG.[2023]

A study in Malawi suggests that using a cofinancing approach for funding structural interventions, like keeping adolescent girls in school, can lead to better resource allocation and minimize welfare loss compared to isolated sector evaluations.

Cofinancing allows for the integration of multiple health and development goals, highlighting the importance of cross-sectoral coordination to ensure effective implementation of interventions that can reduce HIV vulnerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financing structural interventions: going beyond HIV-only value for money assessments. Remme, M., Vassall, A., Lutz, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5678381/

The Effectiveness of HIV Prevention Interventions in ... The combined obtained effect (RR = 0.59; 95% CI = 0.46, 0.75) indicated that preventive interventions significantly reduced the risk of STIs by 41%. No ...

2. jahonline.org jahonline.org/article/S1054-139X(24)00296-9/fulltext

Evidence Gaps in Economic Evaluations of HIV ... This systematic review seeks to collate evidence on the health and economic impact of HIV interventions targeting YPLWH and to identify gaps in the available ...

3. cdc.gov cdc.gov/high-impact-prevention/php/index.html

High-Impact Prevention This resulted in approximately 18,000 new HIV diagnoses. This helped prevent $1.2 billion in direct medical costs because every $1.00 spent on ...

4. link.springer.com link.springer.com/article/10.1007/s10461-025-04745-4

A Systematic Review of the Effectiveness of HIV Prevention ... Most studies found that interventions were associated with positive health-related changes, such as reduced HIV incidence, increased condom use ...

5. californiaaidsresearch.org californiaaidsresearch.org/funded-research/implementation-science.html

Implementation Science - CHRP Our overarching research goal is to design and test the effectiveness of a culturally tailored HIV prevention intervention mobile app for young Black girls ( ...

6. withpower.com withpower.com/trial/phase-feasibility-studies-1-2024-8329c

Microeconomic Intervention for HIV Prevention (Secure Trial) The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37884052/

Which Intervention Synergies Maximize AGYW's HIV ... For AG, HIV testing improved (from 73% to 83%) with exposure to all interventions, condom use improved with Econ (from 33% to 46%), ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025001087

The effects of the Determined, Resilient, Empowered, AIDS ... Evidence suggests that DREAMS results in a reduction in HIV incidence and may reduce sexually transmitted infections (STI).