Economic Support and Education Intervention for HIV Prevention in Young Adults

(ENSPIRE Trial)

Overseen By Adriana Parker, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Age, Consent, others

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

Compensation: Varies

Number of Visits: 6

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining job support with HIV prevention education can improve economic stability and safe behaviors in young adults. Participants will be divided into two groups: one will receive job opening information via text, while the other will receive job information plus HIV prevention messages, educational sessions, economic resources, and mentoring as part of the Enhanced Microenterprise Intervention. This trial suits young adults aged 18-24 who have been economically vulnerable and sexually active in the past year, live in Baltimore, and have a mobile phone capable of receiving texts. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance both economic and health outcomes for young adults.

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 this intervention is safe?

Research shows that the Enhanced Microenterprise Intervention, which combines financial support with HIV prevention education, offers a promising approach for young adults. Studies have found that participants generally appreciate this type of program and find it useful for learning about money management and sexual health.

Available studies do not report any major safety issues or negative effects, suggesting that participants handle the program well. The program focuses on providing job information, educational sessions, and mentoring, which typically do not involve safety risks. However, if you decide to join, share any concerns or experiences with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional HIV prevention methods that often focus solely on medical interventions like antiretroviral therapy or pre-exposure prophylaxis (PrEP), the Enhanced Microenterprise Intervention takes a broader approach. This treatment is unique because it combines economic support and education with HIV prevention strategies. Participants receive job announcements along with text messages about HIV prevention, educational sessions, economic resources, and mentoring. Researchers are excited about this approach because it addresses the socioeconomic factors that contribute to HIV risk, potentially leading to more sustainable prevention outcomes by empowering young adults economically and educationally, alongside conventional medical advice.

What evidence suggests that this trial's interventions could be effective for HIV prevention in young adults?

This trial will compare an Enhanced Microenterprise Intervention with a control group. Research has shown that programs assisting people in starting small businesses can reduce risky sexual behaviors and improve job opportunities for those in need. One study found that participants in these programs secured more jobs and had fewer instances of unprotected sex over time. Participants in the intervention arm will receive job announcements, HIV prevention text messages, educational sessions, economic resources, and mentoring. These programs aim to improve financial stability and encourage safer practices. Overall, these efforts appear promising in promoting healthier behaviors and better economic outcomes, which can aid in preventing HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Larissa Jennings Mayo-Wilson, PhD MHS

Principal Investigator

University of North Carolina, Chapel Hill

Adriana Parker, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for African-American young adults aged 18-24 living in Baltimore who have faced economic challenges in the past year, are sexually active, and can receive text messages on their mobile phones. It's not open to those under 18 or over 24, or anyone unwilling to consent to participate.

Inclusion Criteria

You have been economically disadvantaged in the past 12 months.

You reside in Baltimore.

You have African ancestry.

Exclusion Criteria

I am 17 years old or younger.

I am older than 24 years.

Unwilling to provide consent for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either job announcements only or job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages

12 weeks

Weekly text messages

Follow-up

Participants are monitored for economic stability and HIV preventive behaviors through surveys

24 months

Surveys at 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Microenterprise Intervention

Trial Overview The study compares two groups: one just gets job alerts via texts (control), while the other also gets HIV prevention education, mentoring, a small grant, and texts about making smart choices to avoid HIV (intervention). Participants will be randomly placed into these groups.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Group II: Control Experimental Treatment 1 Intervention

Job announcements only

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The EMERGE intervention, a 20-week program aimed at economically-vulnerable African-American young adults, showed promising feasibility with a high retention rate of 95% among the 38 participants, indicating strong engagement with the program.

Participants in the experimental group experienced significant improvements, with employment rates rising from 32% to 83% and reported unprotected sex decreasing from 79% to 58%, suggesting that economic strengthening can positively impact both employment and sexual risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial. Jennings Mayo-Wilson, L., Coleman, J., Timbo, F., et al.[2022]

Microenterprise development interventions, particularly those targeting women and sex workers, have shown significant reductions in sexual risk behaviors associated with HIV/STI, suggesting a promising approach for prevention.

While the studies reviewed indicated potential benefits, particularly for sex workers, more research is necessary to understand how to effectively integrate microenterprise development into broader HIV control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microenterprise development interventions for sexual risk reduction: a systematic review. Cui, RR., Lee, R., Thirumurthy, H., et al.[2021]

Economic empowerment, particularly through microfinance programs, is suggested to play a role in reducing the spread of HIV/AIDS, especially among women, but the evidence supporting this claim is mixed.

The paper calls for further research to clarify the effectiveness of integrating economic programs with HIV/AIDS prevention strategies, highlighting the need to address existing ambiguities in the current evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfinance and HIV/AIDS prevention: assessing its promise and limitations. Dworkin, SL., Blankenship, K.[2022]

A study of medically stable clients in HIV care revealed a significant unmet need for business capital, suggesting that microfinance and business training could greatly benefit individuals living with HIV/AIDS.

Participants who received microcredit loans demonstrated high repayment rates and significant increases in disposable income, profits, and savings, indicating the effectiveness of integrating economic support with HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Microfinance Program Targeting People Living with HIV in Uganda: Client Characteristics and Program Impact. Linnemayr, S., Buzaalirwa, L., Balya, J., et al.[2022]

The economic empowerment intervention significantly improved adherence to HIV treatment among adolescents after 24 months, indicating that financial support and training can enhance health outcomes.

Participants in the intervention group also showed higher school enrollment and reported better savings, suggesting that economic empowerment can lead to broader improvements in educational and financial stability for adolescents living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-term (5-year) Impact of a Family Economic Empowerment Intervention on Adolescents Living with HIV in Uganda: Analysis of Longitudinal Data from a Cluster Randomized Controlled Trial from the Suubi+Adherence Study (2012-2018). Brathwaite, R., Ssewamala, FM., Mutumba, M., et al.[2023]

Microenterprise programs for low-income women living with HIV in Alabama can potentially improve health outcomes through mechanisms like social support, enhanced self-esteem, structured daily routines, and financial stability, as identified in a qualitative study involving 46 women and 14 stakeholders.

However, there are risks associated with these programs, such as the potential for unwanted disclosure of HIV status, stigma, and loss of insurance benefits, which need to be carefully managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Value of Microenterprise for Low-Income Women Living with HIV in Alabama. Walcott, M., Kempf, MC., Merlin, JS., et al.[2020]

The EMERGE trial is a feasibility study involving 40 economically-vulnerable African-American young adults in Baltimore, focusing on a microenterprise intervention combined with text message nudges to reduce HIV risk and improve employment.

Participants will receive either job information or a comprehensive program that includes job info, HIV prevention education, and business support, with outcomes assessed to determine the feasibility of a larger trial aimed at reducing sexual risk behaviors and increasing HIV preventive practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial. Mayo-Wilson, LJ., Glass, NE., Ssewamala, FM., et al.[2022]

In a study involving 1773 adolescents in South Africa, combining economic strengthening (ES) and HIV-prevention education did not significantly reduce sexually transmitted infections (STIs) compared to control groups, indicating that these interventions alone or together may not be sufficient for STI prevention.

However, the combined ES+HIV intervention did improve HIV knowledge significantly compared to the control and ES-only groups, suggesting that while STI prevalence was not affected, educational outcomes may benefit from a multisectoral approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the integration of an economic strengthening and HIV prevention education programme on the prevalence of sexually transmitted infections and savings behaviours among adolescents: a full-factorial randomised controlled trial in South Africa. Burke, HM., Chen, M., Murray, K., et al.[2023]

The CDC explored the potential of microenterprise as a strategy for HIV/AIDS prevention, particularly among poor African American women in the southern United States, highlighting the link between poverty and increased infection risk.

Participants from various fields emphasized that income generated from microenterprise can improve health outcomes, leading to recommendations for multifaceted interventions to address HIV/AIDS and other public health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing poverty as risk for disease: recommendations from CDC's consultation on microenterprise as HIV prevention. Stratford, D., Mizuno, Y., Williams, K., et al.[2022]

Formative research involving focus groups with young African American women identified that microenterprise activities should focus on boosting self-esteem and employability to help reduce financial dependence, which is crucial for HIV prevention.

The study highlights the potential for a novel HIV prevention intervention in the U.S. that addresses poverty as a key social determinant of health, specifically targeting unemployed or underemployed women at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing poverty and HIV using microenterprise: findings from qualitative research to reduce risk among unemployed or underemployed African American women. Prather, C., Marshall, K., Courtenay-Quirk, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6637550/

Microenterprise intervention to reduce sexual risk ... This study will be one of the first U.S.-based feasibility randomized clinical trials of an HIV prevention microenterprise intervention for economically- ...

2. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/microenterprise-intervention-to-reduce-sexual-risk-behaviors-and--2

Microenterprise Intervention to Reduce Sexual Risk ... Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American ...

3. withpower.com withpower.com/trial/phase-financial-stress-8-2023-78b55

Economic Support and Education Intervention for HIV ... For example, a study found that participants in a microenterprise intervention reported higher employment rates and lower rates of unprotected sex over time.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT03766165/Prot_SAP_000.pdf

Microenterprise Intervention to Reduce Sexual Risk Behaviors in ... Executive Summary: The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to ...

5. link.springer.com link.springer.com/article/10.1007/s10461-020-02931-0

A Feasibility Randomized Clinical Trial | AIDS and Behavior This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African- ...

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09904-x

Acceptability of a feasibility randomized clinical trial of a ... Microenterprise interventions are acceptable ways of providing young adults with important financial and sexual health content to address HIV ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03766165

Microenterprise Intervention to Reduce Sexual Risk ... The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk ...