A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho

NCT ID: NCT03762187

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2015-01-31

Brief Summary

This study is interested in the stress associated with being HIV positive and looking at ways to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats and stressors: the burden of illness, loss of work, stigmatization, and the chance of death. The study investigates the use of self-affirmation to reduce some of these threats and stressors. Self-affirmation may helping people to cope with these threats and stressors by reminding individuals of other valued aspects of themselves, thus reducing the impact, both psychologically and physiologically, of these threats. Experimentally induced affirmations in which individuals are asked to write about values that are important to the self have been shown to reduce physiological stress among healthy student populations (Sherman, Bunyan, Creswell, & Jaremka, 2009).

This research will be conducted in collaboration with the global health organizations, PSI who is already providing counseling to those living with HIV on how to reduce the spread of HIV and how to live a healthy life with HIV. These counseling sessions take place at local clinics and hospitals while individuals are waiting to be seen for treatment and are completely voluntary.

Conditions

Self-affirmation Plus Positive Living Counseling; Counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Self-affirmation

Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.

Group Type: EXPERIMENTAL

Self-affirmation

Intervention Type: BEHAVIORAL

Individuals select important values and then write about why that value is important to them.

Positive living counseling

Intervention Type: BEHAVIORAL

Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.

Positive living counseling

Participants completed the standard counseling provided by the clinic (treatment as usual control condition).

Group Type: ACTIVE_COMPARATOR

Positive living counseling

Intervention Type: BEHAVIORAL

Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.

Interventions

Self-affirmation

Individuals select important values and then write about why that value is important to them.

Intervention Type: BEHAVIORAL

Positive living counseling

Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV+
• A CD4 count of less than or equal to 500 cells/mm3 or have significant symptomatology and HIV co-illness (WHO HIV clinical stage 3 or 4) to be eligible to start antiretroviral therapy

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fulbright

OTHER

Sponsor Role: collaborator

Ministry of Health, Lesotho

OTHER_GOV

Sponsor Role: collaborator

University of California, Santa Barbara

OTHER

Sponsor Role: lead

Responsible Party

David Sherman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

13-0333

Identifier Type: -

Identifier Source: org_study_id