Clinical trial NCT03809364: Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Couple-based intervention
Antiretroviral therapy
South Africa
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: Human Sciences Research Council
name: University of Washington
name: Canadian Institutes of Health Research (CIHR)
name: Swiss Tropical & Public Health Institute
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of couples assigned to START Together who agree to enroll in the intervention
timeFrame: Approximately 8 weeks post-randomization
measure: Average score on the 14-item Applied Mental Health Research group's feasibility subscale
timeFrame: Approximately 8 weeks post-randomization
measure: Percentage of couples assigned to START Together who complete all treatment sessions
timeFrame: Approximately 8 weeks post-randomization
measure: Average number of START Together sessions attended
timeFrame: Approximately 8 weeks post-randomization
measure: Average score on the 15-item Applied Mental Health Research group's acceptability subscale
timeFrame: Approximately 8 weeks post-randomization
measure: Average percentage of session content and process items that were completed correctly by the interventionist
timeFrame: Approximately 8 weeks post-randomization
Secondary outcomes:
measure: Viral suppression for women
timeFrame: Change from baseline assessment to approximately 12 weeks post-randomization
measure: HIV medication adherence for women
timeFrame: Change from baseline assessment to approximately 8 weeks post-randomization
measure: HIV medication adherence for women
timeFrame: Change from baseline assessment to approximately 12 weeks post-randomization
measure: Engagement in HIV care for men
timeFrame: Change from baseline assessment to approximately 12 weeks post-randomization
measure: Relationship functioning (women and men)
timeFrame: Change from baseline assessment to approximately 8 weeks post-randomization
measure: Relationship functioning (women and men)
timeFrame: Change from baseline assessment to approximately 12 weeks post-randomization
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu-Natal
Study officials:
References:
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.
citation: 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.
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.