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AzTrials

Human Immunodeficiency VirusNCT03809364

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

A study testing START Together in people with Human Immunodeficiency Virus, run by University of Maryland, College Park at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
START Together
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Africa
Study dates
1 Nov 2021to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Human Sciences Research Council

    Pietermaritzburg, KwaZulu-Natal

Other trials in South Africa

About this study

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

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.

Read the 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.

Being tested
START Together
Keywords
Couple-based intervention, Antiretroviral therapy, South Africa
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • START TogetherBehavioural

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

Study groups in NCT03809364
Study groupRoleWhat they receive
START TogetherExperimentalCouples 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.
Receives: Behavioral: START Together
Standard of Care (SOC)No interventionCouples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Feasibility of START Together intervention

    Measured: Approximately 8 weeks post-randomization

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

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

    Measured: Approximately 8 weeks post-randomization

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

    Acceptability of START Together intervention

    Measured: Approximately 8 weeks post-randomization

  4. Average number of START Together sessions attended

    Acceptability of START Together intervention

    Measured: Approximately 8 weeks post-randomization

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

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

    Measured: Approximately 8 weeks post-randomization

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

    START Together intervention fidelity

    Measured: Approximately 8 weeks post-randomization

Secondary outcomes (6)

  1. Viral suppression for women

    Viral load in dried blood spots or based on clinic records (past 30 days)

    Measured: Change from baseline assessment to approximately 12 weeks post-randomization

  2. HIV medication adherence for women

    Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence

    Measured: Change from baseline assessment to approximately 8 weeks post-randomization

  3. HIV medication adherence for women

    Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence

    Measured: Change from baseline assessment to approximately 12 weeks post-randomization

  4. 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.

    Measured: Change from baseline assessment to approximately 12 weeks post-randomization

  5. 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.

    Measured: Change from baseline assessment to approximately 8 weeks post-randomization

  6. 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.

    Measured: Change from baseline assessment to approximately 12 weeks post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start1 Nov 2021
  3. Primary completion11 Oct 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809364
Sponsor's protocol ID
395623
Status last verified
Dec 2023
First submitted
9 Jan 2019
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26608175

  • 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.

    PubMed 24129466

  • 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.

    PubMed 26599699

Questions about this trial

What is this clinical trial studying?

A study testing START Together in people with Human Immunodeficiency Virus, run by University of Maryland, College Park at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of couples assigned to START Together who agree to enroll in the intervention (time frame: Approximately 8 weeks post-randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809364, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.

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