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

Human Immunodeficiency Virus Clinical Trial

Official title:

Supporting Treatment for Anti-Retroviral Therapy (START) Together: Development of a Couple-based Medication Adherence Intervention for HIV-positive Women and Their Male Partners in Sweetwaters, South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809364
• Other study ID #: 395623
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2023
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

South Africa (SA) has one of the highest global HIV burdens with clear gender disparities. For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women, in comparison, have high rates of HIV testing and are linked to care through antenatal services, but only 45% are virally suppressed on antiretroviral therapy (ART). Thus, tailored interventions for HIV are needed. In order to end the AIDS epidemic, the ambitious "90-90-90" goal was developed by UNAIDS to test, treat, and maintain medication adherence for 73% of HIV-positive individuals. Separate gender-specific interventions have been developed along the HIV care cascade to treat the different needs of men and women. However, no study to date has used one intervention to concurrently meet the unique HIV-related needs for women and men. Couple-based interventions (CBIs) can achieve this goal. CBIs are more efficacious than interventions delivered to individuals in enhancing a number of HIV protective behaviors. HIV is also primarily transmitted in the context of stable heterosexual relationships in sub-Saharan Africa; about 50% of new infections occur in serodiscordant relationships, making the use of a CBI especially relevant. The purpose of this study is to strengthen the HIV care cascade in SA by developing a CBI that concurrently addresses the needs of women and men to meet the UNAIDS' HIV goals. This study will be conducted in the province of KwaZulu-Natal, SA. HIV-positive women who are in a heterosexual relationship and non-adherent to ART will be recruited to participate in the study with their male partners. Twenty couples will be recruited and randomized to either receive the START Together program or to the control condition and followed for 12 weeks thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Report of moderate or severe relationship violence past year

• Either partner previously participated in a couple-based HIV prevention or treatment program

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Pietermaritzburg	KwaZulu-Natal

Sponsors (5)

Lead Sponsor	Collaborator
University of Maryland, College Park	Canadian Institutes of Health Research (CIHR), Human Sciences Research Council, Swiss Tropical & Public Health Institute, University of Washington

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of couples assigned to START Together who agree to enroll in the intervention	Feasibility of START Together intervention	Approximately 8 weeks post-randomization
Primary	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
Primary	Percentage of couples assigned to START Together who complete all treatment sessions	Acceptability of START Together intervention	Approximately 8 weeks post-randomization
Primary	Average number of START Together sessions attended	Acceptability of START Together intervention	Approximately 8 weeks post-randomization
Primary	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
Primary	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	Viral suppression for women	Viral load in dried blood spots or based on clinic records (past 30 days)	Change from baseline assessment to approximately 12 weeks post-randomization
Secondary	HIV medication adherence for women	Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence	Change from baseline assessment to approximately 8 weeks post-randomization
Secondary	HIV medication adherence for women	Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence	Change from baseline assessment to approximately 12 weeks post-randomization
Secondary	Engagement in HIV care for men	Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.	Change from baseline assessment to approximately 12 weeks post-randomization
Secondary	Relationship functioning (women and men)	Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.	Change from baseline assessment to approximately 8 weeks post-randomization
Secondary	Relationship functioning (women and men)	Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.	Change from baseline assessment to approximately 12 weeks post-randomization