HIV Infections, Pre-exposure Prophylaxis
Conditions
Keywords
PrEP, HIV prevention, Adolescent girls and young women, Female sex workers, South Africa
Brief summary
The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.
Detailed description
The overall aim of this trial is to investigate which PrEP support strategies most effectively and efficiently optimize(s) PrEP persistence among female sex workers (FSW) and adolescent girls and youth women (AGYW) in South Africa. The trial will be implemented by TB HIV Care, a South African non-profit organization that provides direct HIV service delivery to FSW and AGYW across 10 districts in South Africa. The investigators plan to individually randomize 304 FSW and AGYW at the TB HIV Care site in uMgungundlovu, KwaZulu-Natal, to a fractional factorial trial, randomizing combinations of four separate strategies to support PrEP continuation. As fthe strategies are being tested, this results in 16 different intervention/study conditions, with one condition serving as a control where FSW and AGYW will receive the standard of care and no additional PrEP support. The other 15 conditions will be a combination of the standard of care alongside different PrEP delivery and support strategies implemented by TB HIV Care: case management, food vouchers, peer support buddies, and PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use and persistence, so that these services can be scaled up to other TB HIV Care sites. By utilizing the fractional factorial design in alignment the multiphase optimization strategy framework (MOST) the trial is feasible to conduct even with 16 arms, as the design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.
Interventions
BEHAVIORALCase management
Participants will receive case management delivered by a peer with PrEP experience/success for seven months, with the goal of improving self-efficacy to take PrEP. The intention of this intervention is to help participants to develop individualized strategies to address and overcome barriers to PrEP use, as well as develop disclosure strategies. This strategy includes weekly face-to-face support with the case manager for the first month of the trial, followed by monthly face-to-face support for the remainder of the trial follow up period. The strategy will also include client-initiated on-demand phone consultation with the case manager and mental health/substance use screening and referrals. Participants randomized to this strategy may also opt into daily timed PrEP pill-taking reminders via short message service (SMS).
BEHAVIORALFood vouchers
Participants will be given food vouchers with a value of 200 South African Rand at the time of PrEP initiation and at 1- and 4-month standard of care visits at which clinical checkups and PrEP refills are provided. The goal of these vouchers is to improve participants' capacity to persist on PrEP. While PrEP can be taken without food, some experience increased side effects or prefer to take pills with food, making adherence difficult if they cannot afford food at times.
BEHAVIORALPrEP support buddy
Participants will identify a person in their network (such as a friend, partner, parent) that they wish to support them in their PrEP usage, with the goal of improving participants' motivation and self-efficacy to persist on PrEP and providing social support to facilitate ongoing PrEP use. Support buddies selected by FSW and AGYW randomized to this intervention will receive a one-time training session on PrEP and support strategies as well as informational materials and text reminders to assist them in providing ongoing PrEP support.
BEHAVIORALCommunity-based PrEP pickup points
Participants will be able to pick up PrEP from alternative pick-up points within the community that are convenient for them, with the goal of making PrEP more accessible to participants. Ten pickup points will be established at existing Hubs of Hope throughout the subdistricts served by the TB HIV Care programme. Hubs of Hope are based in the War Rooms within subdistricts, where the TB HIV Care programme operates, and serve as meeting places for service users to receive support searching for jobs, completing online courses, and other personal development activities to support a multi-sectoral approach to health. A TB HIV Care ambassador is based at each Hub of Hope to coordinate activities and provide support to service users. Participants who choose to use pick-up points will have the option of either completing an HIV self-test or testing with the on-site TB HIV Care staff to confirm HIV-negative status prior to receipt of PrEP refills.
Sponsors
Johns Hopkins Bloomberg School of Public Health
TB HIV Care
Unity Health Toronto
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Initiated PrEP within the past 48 hours by the TB HIV Care PrEP programme in uMgungundlovu through the female sex worker (FSW) or adolescent girls and young women (AGYW) PrEP programme teams
Exclusion criteria
* Not eligible for PrEP * Currently on PrEP, but initiated onto PrEP more than 48 hours previously * Under 16 years of age if AGYW OR under 18 years of age if FSW
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Persistence at 7 Months After PrEP Initiation | Month 7 | Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. |
| PrEP Adherence at 7 Months After PrEP Initiation | Month 7 | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will not be included in this outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Persistence at 1 Month After PrEP Initiation | Month 1 | Participants who had PrEP in their possession 1-month after initiation, or returned for their 1-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. |
| PrEP Persistence at 4 Months After PrEP Initiation | Month 4 | Participants who had PrEP in their possession 4-months after initiation, or returned for their 4-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. |
| PrEP Persistence at 13 Months After PrEP Initiation | Month 13 | Participants who had PrEP in their possession 13-months after initiation, or returned for their 13-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. |
| PrEP Adherence at 7 Months After PrEP Initiation Among Trial Participants Who Provided Dried Blood Spot Samples | Month 7 | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Those who do not return at 7-months or do not provide a DBS sample will be excluded from this analysis. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORSheree Schwartz, PhD, MPH
Johns Hopkins Bloomberg School of Public Health
PRINCIPAL_INVESTIGATORHarry Hausler, MD, PhD, MPH
TB HIV Care
Participant flow
Recruitment details
Recruitment took place at the TB HIV Care drop-in center in uMgungundlovu, KwaZulu-Natal from April to September 2024. The first participant was enrolled on April 16, 2024 and the last participant was enrolled September 6th, 2024.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 4.9 |
| Age, Customized Age cateogry 16-17 | 16 Participants |
| Age, Customized Age cateogry 18-24 | 14 Participants |
| Age, Customized Age cateogry 25-29 | 4 Participants |
| Age, Customized Age cateogry 30-34 | 1 Participants |
| Age, Customized Age cateogry 35-39 | 7 Participants |
| Age, Customized Age cateogry 40+ | 0 Participants |
| Alcohol use in the past year Monthly or less | 9 Participants |
| Alcohol use in the past year Never | 9 Participants |
| Alcohol use in the past year Two or more times per month | 5 Participants |
| Anxiety | 86 Participants |
| Depression | 105 Participants |
| Education Currently studying | 8 Participants |
| Education Grade 10-11 | 0 Participants |
| Education Grade 12 (Matric) | 5 Participants |
| Education Post-secondary | 3 Participants |
| Education Up to Grade 9 | 0 Participants |
| Ever pregnant | 160 Participants |
| Food insecurity | 2 Participants |
| History of forced sex | 0 Participants |
| History of physical violence | 7 Participants |
| Homeless in the past 6 months | 0 Participants |
| Living situation Family Home | 13 Participants |
| Living situation Other | 2 Participants |
| Living situation Partner's place | 7 Participants |
| Living situation Renting own place | 78 Participants |
| Perceived HIV risk A little | 5 Participants |
| Perceived HIV risk A lot | 22 Participants |
| Perceived HIV risk Not at all | 2 Participants |
| Perceived HIV risk Prefer not to answer | 1 Participants |
| Perceived HIV risk Somewhat | 6 Participants |
| Population Adolescent girls and young women | 11 Participants |
| Population Female sex worker | 7 Participants |
| Prior PrEP use | 85 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 304 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Africa | 19 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 1 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 1 / 19 | 1 / 20 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 | 1 / 19 |
Outcome results
None listed