Clinical trial NCT03762187: A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho
Official title: Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-affirmation Plus Positive Living Counseling
Counseling
Lead sponsor: University of California, Santa Barbara
Sponsor class: OTHER
Collaborators: name: Fulbright
name: Ministry of Health, Lesotho
First posted: 2018-12-03
Enrollment: 389
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants are randomized to one of the two conditions.
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Post-intervention survey conducted immediately after intervention session
measure: Intrusion subscale of impact of events scale
timeFrame: Post-intervention survey conducted immediately after intervention session
measure: Concerns about dying
timeFrame: Post-intervention survey conducted immediately after intervention session
measure: Distressing emotions related to HIV
timeFrame: Post-intervention survey conducted immediately after intervention session
measure: Future behavioral intentions
timeFrame: Post-intervention survey conducted immediately after intervention session
Secondary outcomes:
measure: Physical health measures
timeFrame: Post-intervention survey conducted immediately after intervention session
Other outcomes:
Locations:
Study officials:
References: