Human Immunodeficiency Virus
Conditions
Keywords
Couple-based intervention, Antiretroviral therapy, South Africa
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.
Interventions
BEHAVIORALSTART Together
Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
Sponsors
Human Sciences Research Council
University of Washington
Canadian Institutes of Health Research (CIHR)
Swiss Tropical & Public Health Institute
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average percentage of session content and process items that were completed correctly by the interventionist | Approximately 8 weeks post-randomization | START Together intervention fidelity |
| Average score on the 14-item Applied Mental Health Research group's feasibility subscale | Approximately 8 weeks post-randomization | Feasibility of START Together intervention. Higher scores indicate greater feasibility. |
| Percentage of couples assigned to START Together who complete all treatment sessions | Approximately 8 weeks post-randomization | Acceptability of START Together intervention |
| Average number of START Together sessions attended | Approximately 8 weeks post-randomization | Acceptability of START Together intervention |
| Average score on the 15-item Applied Mental Health Research group's acceptability subscale | Approximately 8 weeks post-randomization | Acceptability of START Together intervention. Higher scores indicate greater acceptability. |
| Percentage of couples assigned to START Together who agree to enroll in the intervention | Approximately 8 weeks post-randomization | Feasibility of START Together intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV medication adherence for women | Change from baseline assessment to approximately 8 weeks post-randomization | Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence |
| Engagement in HIV care for men | Change from baseline assessment to approximately 12 weeks post-randomization | Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used. |
| Relationship functioning (women and men) | Change from baseline assessment to approximately 8 weeks post-randomization | 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. |
| Viral suppression for women | Change from baseline assessment to approximately 12 weeks post-randomization | Viral load in dried blood spots or based on clinic records (past 30 days) |
Countries
South Africa
Outcome results
None listed