1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University

About this trial

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV.

Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits).

Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cis-gender female

Black or African American

≥ Age 18

Living with HIV

Disqualifiers

Not a Cis-gender female

Not Black or African American

≤ Age17 or younger

Not living with HIV

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1MoreStep

    Behavioral

    Cognitive behavioral intervention to reduce HIV and IPV stigma.

  • 1MoreStepControl

    Behavioral

    This is an equal attention control group.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 1MoreStep InterventionExperimental treatment 1 intervention
Group B: Equal Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of study as measured by the Treatment Acceptance Scale

This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.

Time frame
Week 7
2

Acceptability of study as measured by the Treatment Acceptance Scale

This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.

Time frame
3 month follow up
3

Acceptability of study as documented in in-depth interviews

Interviews will assess program fit, facilitators and barriers to participation, and use of 1MoreStep intervention skills.

Time frame
3 month follow up
4

Feasibility of study as measured by session attendance

Session attendance

Time frame
Week 7

Secondary outcomes

1

Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index

Four subscale scores will be evaluated independent of one another: accessing formal resources; accessing informal resources; placating strategies; and safety planning. Scores can range from a minimum of 0 to a maximum of 28. Scores which increase \>1 in magnitude from baseline will indicate increased use of Intimate Partner Violence safety strategies by the participant, and therefore would be a positive outcome.

Time frame
Baseline, Week 7 and 3 month follow up
2

Change in Self-reported HIV Care Engagement in the form of ART medication use

Self-reported use of ART medication (yes or no)

Time frame
Baseline, Week 7 and 3 month follow up
3

Change in Use of prescription ART medication as assessed by chart review of HIV Care Engagement

Chart review regarding use of prescription ART medication (yes or no)

Time frame
Baseline, 3 month follow up and 1 year
4

Change in Number of HIV Care Provider visits as assessed by self-reported HIV Care Engagement

Self-reported HIV Care Engagement in the form of number of HIV Care Provider visits within the last year.

Time frame
Baseline, Week 7 and 3 month follow up

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator