Trial Outcomes & Findings for Use of Antiretroviral (ARV) Drug Levels in Dried Blood Spots (DBS) to Assess and Manage ART Adherence in South Africa (NCT NCT04333498)

Last Updated: 2023-01-20

Results Overview

Tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) is used as a biomarker of antiretroviral therapy (ART) adherence. Recent treatment studies have shown that TFV-DP predicts future viremia in persons with HIV (PWH). Whole blood for DBS was collected at each study visit by venipuncture. To prepare the DBS, 25 mcl of whole blood were spotted five times onto a Whatman 903 ProteinSaver card and dried for a minimum of 3hrs and up to overnight before being individually packaged in a plastic bag with dessicant and a humidity indicator.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

5 Months

Results posted on

2023-01-20

Participant Flow

60 people with HIV (PWH) were recruited from an ART clinic in Cape Town. Recruitment commenced in 09/2020 and ended 02/2021.

No pre-assignment details to note, all participants were randomized on the day they were enrolled.

Participant milestones

Participant milestones
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS This arm of participants will receive monthly feedback from research staff on their ART adherence measured through TFV-DP levels in dried blood spots (DBS). Adherence change in this group will later be measured through TFV-DP levels, Wisepill use, Viral Load, and self-report.	No Feedback This arm of participants will not receive monthly feedback through TFV-DP levels in DBS. This group is receiving standard of care (control).
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS This arm of participants will receive monthly feedback from research staff on their ART adherence measured through TFV-DP levels in dried blood spots (DBS). Adherence change in this group will later be measured through TFV-DP levels, Wisepill use, Viral Load, and self-report.	No Feedback This arm of participants will not receive monthly feedback through TFV-DP levels in DBS. This group is receiving standard of care (control).
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Use of Antiretroviral (ARV) Drug Levels in Dried Blood Spots (DBS) to Assess and Manage ART Adherence in South Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS n=30 Participants This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.	No Feedback n=30 Participants This arm of participants will not receive monthly feedback through TFV-DP levels in DBS.	Total n=60 Participants Total of all reporting groups
Age, Continuous	37 years n=5 Participants	41 years n=7 Participants	39 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Hematocrit	33 % of red blood cells n=5 Participants	32 % of red blood cells n=7 Participants	32 % of red blood cells n=5 Participants
Months on ART	68 Months n=5 Participants	52 Months n=7 Participants	56 Months n=5 Participants
Baseline TFV-DP Result	1163 fmol/punch STANDARD_DEVIATION 856 • n=5 Participants	1011 fmol/punch STANDARD_DEVIATION 433 • n=7 Participants	1087 fmol/punch STANDARD_DEVIATION 677 • n=5 Participants

PRIMARY outcome

Timeframe: 5 Months

Outcome measures

Outcome measures
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS n=30 Participants This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.	No Feedback n=30 Participants This arm of participants will not receive monthly feedback through TFV-DP levels in DBS.
TFV-diphosphate (TFV-DP) Drug Level	1377.82 fentomole/punch Standard Deviation 846.45	1156.79 fentomole/punch Standard Deviation 653.99

PRIMARY outcome

Timeframe: 5 months

Outcome measures

Outcome measures
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS n=30 Participants This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.	No Feedback n=30 Participants This arm of participants will not receive monthly feedback through TFV-DP levels in DBS.
Viral Load (VL) Assay	67.07 copies/ml Standard Deviation 622.12	1170.17 copies/ml Standard Deviation 8450.75

PRIMARY outcome

Timeframe: 5 months

The number of days recorded as intake on electronic medical device (EMD) divided by days on study

Outcome measures

Outcome measures
Measure	Receiving Feedback From TFV-DP Drug Levels Through DBS n=30 Participants This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.	No Feedback n=30 Participants This arm of participants will not receive monthly feedback through TFV-DP levels in DBS.
Electronic Adherence (EA) Percentages	81 Percentage of days recorded as intake Standard Deviation 21	79 Percentage of days recorded as intake Standard Deviation 22

Adverse Events

Receiving Feedback From TFV-DP Drug Levels Through DBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Program Manager

New York State Psychiatric Institute/ HIV Center

Phone: 646-774-6904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place