Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa

NCT03809364 | Completed

• 1 other identifier: 395623
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART adherence and enhancing the couple's communication and problem-solving behavior. The study focuses on implementation outcomes (feasibility, acceptability, and fidelity) and preliminary efficacy outcomes (women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning), which will be compared to a control condition of referrals to usual HIV care.

Conditions

Human Immunodeficiency Virus

Keywords

Couple-based intervention; Antiretroviral therapy; South Africa

Outcome Measures

Primary Outcomes (6)

• Percentage of couples assigned to START Together who agree to enroll in the intervention

  Feasibility of START Together intervention

  Approximately 8 weeks post-randomization

• Average score on the 14-item Applied Mental Health Research group's feasibility subscale

  Feasibility of START Together intervention. Higher scores indicate greater feasibility.

  Approximately 8 weeks post-randomization

• Percentage of couples assigned to START Together who complete all treatment sessions

  Acceptability of START Together intervention

  Approximately 8 weeks post-randomization

• Average number of START Together sessions attended

  Acceptability of START Together intervention

  Approximately 8 weeks post-randomization

• Average score on the 15-item Applied Mental Health Research group's acceptability subscale

  Acceptability of START Together intervention. Higher scores indicate greater acceptability.

  Approximately 8 weeks post-randomization

• Average percentage of session content and process items that were completed correctly by the interventionist

  START Together intervention fidelity

  Approximately 8 weeks post-randomization

Secondary Outcomes (6)

• Viral suppression for women

  Change from baseline assessment to approximately 12 weeks post-randomization

• HIV medication adherence for women

  Change from baseline assessment to approximately 8 weeks post-randomization

• HIV medication adherence for women

  Change from baseline assessment to approximately 12 weeks post-randomization

• Engagement in HIV care for men

  Change from baseline assessment to approximately 12 weeks post-randomization

• Relationship functioning (women and men)

  Change from baseline assessment to approximately 8 weeks post-randomization

Study Arms (2)

START Together

EXPERIMENTAL

Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is 5 sessions in length and conducted weekly. Sessions are 60 - 75 minutes. Couples have the option of completing up to 3 additional booster sessions. Total treatment therefore ranges between 5 to 8 sessions.

Behavioral: START Together

Standard of Care (SOC)

NO INTERVENTION

Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).

Interventions

START Together BEHAVIORAL

Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.

START Together

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: HIV-positive women are the target study participants. They will participate in treatment with their male partners.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both partners aged 18 or over
• HIV-positive woman diagnosed ≥ 3 months prior to study entry
• HIV-positive woman demonstrates difficulty with HIV treatment engagement, defined as either self-reported ART adherence difficulties, evidence of missed clinic visits over the past year (collected from medical records), or evidence of being not virally suppressed (≥ 50 copies/mL) in the past year
• In a committed, heterosexual, monogamous romantic relationship for at least 6 months
• Both partners willing to participate in treatment to support women's ART adherence
• Both partners reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa
• Willing to have intervention sessions audio-recorded (if randomized to the intervention group)
• Able to comfortably communicate in either isiZulu or English

You may not qualify if:

• Report of moderate or severe relationship violence past year
• Either partner previously participated in a couple-based HIV prevention or treatment program

Sponsors & Collaborators

• University of Maryland, College Park: lead
• Human Sciences Research Council: collaborator
• University of Washington: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Related Publications (3)

• Crepaz N, Tungol-Ashmon MV, Vosburgh HW, Baack BN, Mullins MM. Are couple-based interventions more effective than interventions delivered to individuals in promoting HIV protective behaviors? A meta-analysis. AIDS Care. 2015;27(11):1361-6. doi: 10.1080/09540121.2015.1112353. Epub 2015 Nov 25.

  PMID: 26608175 BACKGROUND

• Anglemyer A, Horvath T, Rutherford G. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples. JAMA. 2013 Oct 16;310(15):1619-20. doi: 10.1001/jama.2013.278328.

  PMID: 24129466 BACKGROUND

• Bor J, Rosen S, Chimbindi N, Haber N, Herbst K, Mutevedzi T, Tanser F, Pillay D, Barnighausen T. Mass HIV Treatment and Sex Disparities in Life Expectancy: Demographic Surveillance in Rural South Africa. PLoS Med. 2015 Nov 24;12(11):e1001905; discussion e1001905. doi: 10.1371/journal.pmed.1001905. eCollection 2015 Nov.

  PMID: 26599699 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 18, 2019
• Study Start: November 1, 2021
• Primary Completion: October 11, 2022
• Study Completion: December 15, 2022
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)