Menopausal HT for Women Living With HIV (HoT)

Change in vasomotor symptom (VMS) severity

Change in self-reported mean severity of VMS from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following randomization; severity scale is ordinal: none (0), mild (1), moderate (2), severe (3).

Time frame: From 5 weeks prior to randomization to week 12

Change in sleep

Change in total sleep scores from randomization visit to week 12 visit as measured by the Pittsburgh Sleep Quality Index (PSQI). Total sleep score determined by summing responses from seven assessments, where each assessment is scored from 0 (best) to 3 (worst). The minimum possible total sleep score is 0 (best) and the maximum possible score is 21 (worst). Higher total scores suggest more severe sleep problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame: From randomization to week 12

Change in insomnia

Change in total insomnia scores from randomization visit to week 12 visit as measured by the Insomnia Severity Index (ISI). Total insomnia score determined by summing responses from seven assessments, each rated on a Likert 5-point scale, where 0 indicates no problems and 4 indicates severe problems. The minimum possible total insomnia score is 0 (best) and the maximum possible score is 28 (worst). Higher total scores suggest more severe insomnia problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame: From randomization to week 12

Change in quality of life

Change in total health-related quality of life score, from randomization visit to week 12 visit as measured by Menopause specific Quality of life questionnaire (MenQOL). Total health-related quality of life score is determined by averaging responses from four domain-specific scores (vasomotor \[3 items\], physical \[16 items\], psychosocial \[7 items\], sexual functioning \[3 items\], each ranging from 1 (best) to 8 (worst)). Domain-specific scores represent the average score among the items in a domain. The score for each item, ranging from 1 (best) to 8 (worst), represents the sum of the presence of the symptom (1 for no, 2 for yes) and the severity, rated on a Likert 7-point scale (0, not bothered at all to 6, extremely bothered), The minimum possible quality of life score is 1 (best) and the maximum possible score is 8 (worst). Higher scores suggest more severe quality of life problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame: From randomization to week 12

Percentage of participants with adverse events associated with hormone therapy

Adverse events (AE) associated with study treatment with severity grade of 3 or higher as per DAIDS Toxicity grading scale.

Time frame: From randomization to week 12

Percentage of participants with occurrence of abnormal vaginal bleeding

Abnormal vaginal bleeding adverse event defined as any of the following: any report of heavy bleeding, 2 or more episodes of spotting or greater at intervals of \< 21 days among participants in late menopausal transition, any occurrence after 6 weeks of hormone treatment among post-menopausal participants.

Time frame: From randomization to week 12

Percentage of participants with intolerance of hormone therapy

Intolerance of hormone therapy is defined as permanent discontinuation prior to the week 12 visit that was not required per protocol nor recommended due to safety considerations.

Time frame: From randomization to week 12

Change in neurocognitive test results

Change in neurocognition as measured by the neuropsychological (NP) battery from randomization visit to week 12 visit.

Time frame: From randomization to week 12

Change in depression symptoms

Change in depression symptoms score from randomization visit to week 12 visit as measured by Patient Health Questionnaire-9 (PHQ-9). Total depression score determined by summing responses from nine assessments, where each assessment is scored from 0 (not at all) to 3 (nearly every day). The minimum possible total sleep score is 0 (best) and the maximum possible score is 27 (worst). Higher total scores suggest more severe depression problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame: From randomization to week 12

Change in anxiety symptoms

Change in anxiety symptoms score from randomization visit to week 12 as measured by Generalized Anxiety Disorder 7-item (GAD-7). Total anxiety score determined by summing responses from seven Likert assessments, where each assessment is scored from 0 (best) to 3 (worst). The minimum possible total anxiety score is 0 (best) and the maximum possible score is 21 (worst). Higher total scores suggest more severe anxiety problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame: From randomization to week 12

Change in weight

Absolute and Percent change in total body weight from randomization visit to week 12 visit.

Time frame: From randomization to week 12

Change in body mass index (BMI)

Absolute change in BMI from randomization visit to week 12 visit

Time frame: From randomization to week 12

Change in waist circumference

Absolute change in minimum waist circumference from randomization visit to week 12 visit

Time frame: From randomization to week 12

Change in waist-to-hip ratio

Change in waist-to-hip circumference ratio between the randomization visit and the week 12 visit

Time frame: From randomization to week 12

Change in sexual function

Change in total sexual function score from randomization visit to week 12 visit as measured by the female sexual function index (FSFI). Total sexual function score is determined by summing six domain-specific scores (desire \[2 items\], arousal \[4 items\], lubrication \[4 items\], orgasm \[3 items\], satisfaction \[3 items\], and pain \[3 items\]), ranging from 0 (worst) to 6 (best). Domain-specific scores represent the sum of the scores for each item within a domain (ranging from 0 (worst) to 6 (best)), multiplied by a factor to adjust for relative weighting (0.6 for desire; 0.3 for arousal; 0.3 for lubrication; 0.4 for orgasm; 0.4 for satisfaction; and 0.4 for pain). The minimum possible sexual function score is 2 (worst) and the maximum possible score is 36 (best). Lower scores indicate worse sexual function. Change in total score calculated as Week 12 minus baseline. Positive change indicates better outcomes.

Time frame: From randomization to week 12

Percentage of participants with female sexual distress

Female sexual distress defined as, at the week 12 visit, endorsing frequently or always to question regarding how often distressed or bothered about sex life in the past 4 weeks.

Time frame: Week 12 visit