• Alternative methods are chosen in case of emergency or unforeseen circumstances.

• DOTS needs to be a flexible and dynamic process and builds a rapport with the participant, allows clear communication in a respectful non-judgemental manner.

Directly Observed Therapy – IMPAACT 2009 Faeezah Patel, Elizea Horne, Maysseb Masenya, Lee Fairlie, Hedwig Kowo, Sindiswa Nelwamondo, Hermien Gous, Angela Oosthuizen, Sibongile Mncube, Thabile Msomi 

Wits RHI Shandukani Research Centre (SRC), Wits Reproductive Health and HIV Institute, Hillbrow, Johannesburg, South Africa

DOTS

Acknowledgements

Advantages of DOTS

What is DOTS?• It is the internationally recommended strategy

for TB control that has been recognised as highly efficient and cost effective.

• It is a specific strategy, endorsed by the WHO to improve adherence by requiring health workers, community volunteers or family members to observe and record patients taking each dose.

Rationale for DOTS• Patients from all backgrounds, gender, ethnicities

and age groups can have problems with taking medications.

• Patients may be incapable, unreliable or unwilling to take medication.

• DOTS allows the healthcare worker to monitor adherence and side-effects as well as early identification of problems.

• Provides support to participants• Allows for close monitoring and early detection of

problems• Develops a trust relationship• Improves the participant’s quality of healthcare and

linkage to care• Ensures good adherence to medication and

appointments• Ongoing participant education

• Time consuming and labour intensive• May lead to the misconception that the participant

is not trustworthy • Reduces the participant’s right to independence. • Social circumstances

IMPAACT 2009 DOTS at SRC

DOTS Options

Study DescriptionThis is a study evaluating the Pharmacokinetics (PK), Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants.

The purpose is to establish drug thresholds for optimal adherence when FTC/TDF is administered daily under direct observation during pregnancy and in the postpartum period.

Study design: • HIV uninfected women, age 16 to 24 years• 2 components: PK and PrEP • PK Components: Currently active

o Group 1: Ante-natal 14-24 weeks gestational age, singleton pregnancy

o Group 2: Post-natal 6-12 weeks • PrEP Components: Not yet started

o Cohort 1: Women accepting PrEPo Cohort 2: Women NOT accepting PrEP

• Study drug: emtricitabine (FTC) 200mg and tenofovir disoproxil fumarate (TDF) 300mg as a fixed dose combination

• Direct observation of medication doses for 12 weeks.

• Determine the concentration of tenofovir diphosphate (TFV-DP) associated with adequate adherence to FTC/TDF in the defined population. Barriers to DOTS at SRC

Shandukani Research Centre is located within the Hillbrow Health Precinct in Johannesburg, South Africa.

SRC

Hillbrow, Johannesburg

The surrounding urban community it serves consists of key populations, especially young women, migrants and people living with HIV.

IMPAACT 2009 teamWits RHI Shandukani Research Centre TeamIMPAACT 2009 participants - Consent for photography was obtained

Group 1 - PK component (N=4)

PREFERRED DOTS OPTION

In person / on site 4

Time-stamped Video 0

Realtime Video 0

CHANGES TO PREFERRED DOTS OPTIONChange in options -Permanent

0

Change in option - Temporary 4*

Missed DOTS since enrolment 0* non-time stamped video-taken, but not observed* 3 participants did real time video recording

DOTS options and their implications are discussed with participants from pre-screening and reviewed at screening, entry and weekly visits.Participants get to choice a preferred option as well as alternative option for weekdays and weekends.Participant factors which may influence decisions regarding DOTS option: • Distance from residence/work to

SRC• Understanding the importance of

and willingness to take PrEP daily in study

• Access to a smartphone • Access to reliable connectivity• Disclosure concerns, privacy and

confidentiality

Step 1• Participant is contacted prior

to planned visit for reminder• Participant arrives at the

time agreed upon with study PrEP medication. DOTS provider records date and time of contact and then removes medication from the container and gives it to the participant.

Step 4Participant shows the DOTS provider her mouth again 5 minutes post ingestion of the medication 22

Step 2DOTS provider ensures the following:• Right participant,• Right medication,• Right dose

Step 5The DOTS provider records the following on the DOTS tracking log:• PID• Date and time of ingestion• DOTS option used• Whether a dose was repeated

(if yes, reason)The DOTS provider signs and dates the entry

Step 3The participant ingests the medication under observation of the DOTS provider, then opens her mouth and lifts her tongue immediately to show that the medication has been swallowed

Step 6 • Participants wait for 30 min

post ingestion to observe for any vomiting or other side-effects.

• Next DOT visit is confirmed and documented

Conclusion

IMPAACT 2009 – Group 1 statsScreening start date 08 Apr 2019Screening end date 24 Apr 2019Total screening period 17 daysNumber of patients screened 8Number of patients enrolled 4Date of last entry visit 02 May 2019Date of last DOTS (12 week) 25 Jul 2019As at 03 Jun 2019 Last patient

enrolled completed week 4 visit

• All SRC IMPAACT 2009 Group 1 participants selected in-person DOT at site as first choice.

• 100% adherence with DOTS visits for 6 weeks.• All patients arrive at agreed upon times and comply

with agreed upon DOTS options.