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

40 Participants Needed

Trial Summary

What is the purpose of this 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. To meet this aim, the study has the following objectives: 1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color. 2. The determine acceptability of the intervention with transgender women of color.

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 data supports the effectiveness of the SeCuRE intervention treatment for HIV prevention?

Research shows that economic incentives can improve HIV prevention outcomes, such as increasing testing rates and voluntary male circumcision, in certain settings. Additionally, an economic intervention in Uganda significantly improved HIV prevention attitudes among adolescents. ^{1 2 3 4 5}

How is the SeCuRE intervention treatment different from other HIV prevention treatments?

The SeCuRE intervention is unique because it uses economic incentives to encourage HIV prevention behaviors, combining traditional economic theory with insights from psychology to improve outcomes. This approach is different from standard medical treatments as it focuses on changing behavior through financial motivation rather than medication or medical procedures. ^{1 2 6 7 8}

Research Team

Kristi Gamarel, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Conditional economic incentives to improve HIV prevention and treatment in low-income and middle-income countries. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A novel economic intervention to reduce HIV risks among school-going AIDS orphans in rural Uganda. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Disseminating effective behavioral interventions for HIV prevention: a cost analysis of a risk-reduction intervention for drug users. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Threshold analysis and programs for prevention of HIV infection. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Modeling cost-effectiveness of HIV prevention programs. [2009]

6. England pubmed.ncbi.nlm.nih.gov

HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Financing structural interventions: going beyond HIV-only value for money assessments. [2022]