Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal, South Africa
NCT Number: NCT03809364
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pietermaritzburg, KwaZulu-Natal, South Africa
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
Time frame: Approximately 8 weeks post-randomization
Feasibility of START Together intervention
Time frame: Approximately 8 weeks post-randomization
Feasibility of START Together intervention. Higher scores indicate greater feasibility.
Time frame: Approximately 8 weeks post-randomization
Acceptability of START Together intervention
Time frame: Approximately 8 weeks post-randomization
Acceptability of START Together intervention
Time frame: Approximately 8 weeks post-randomization
Acceptability of START Together intervention. Higher scores indicate greater acceptability.
Time frame: Approximately 8 weeks post-randomization
START Together intervention fidelity
Time frame: Change from baseline assessment to approximately 12 weeks post-randomization
Viral load in dried blood spots or based on clinic records (past 30 days)
Time frame: Change from baseline assessment to approximately 8 weeks post-randomization
Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence
Time frame: Change from baseline assessment to approximately 12 weeks post-randomization
Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline assessment to approximately 12 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.
University of Maryland, College Park
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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