SAFER STUDY The Impact, Feasibility, Acceptability - PowerPoint Presentation

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SAFER STUDY

The Impact, Feasibility, Acceptability and Cost-Effectiveness of Safer Conception Strategies for HIV-Discordant Couples in Zimbabwe

Dr. Bismark MatevekeUZ-UCSF Annual Research DayHarare, Zimbabwe05 May 2017

HIV discordance:

a significant driver of new infections30-50% of people with HIV in sub-Saharan Africa are in a stable, HIV-discordant relationship44-60% of new HIV infections are in married, cohabitating HIV-discordant couples

Safer conception strategies

Type of discordance

Strategy

ART

w/viral load

monitoring

PrEP

Semen

washing

Vaginal

insemination

Estimated Risk

Reduction

93-96

%* 63-90%* Up to 100%* Up to 100%*

*Efficacy depends

on adherence

Cohen, et al.

N

Engl

J Med

(2011);

Anglemyer

, et al. Cochrane Database of Systematic Reviews (2011);

Baeten

,

et al

.

N

Engl J Med (2012); Thigpen, et al. N Engl J Med (2012); Zafer, et al. Fertil Steril (2016); Matthews et al, AIDS (2010).

Strategies timed to the fertile period

Couples may choose more than one strategy

Interventional pilot study

123SAFER Study Protocol version 3.1 Dated 10 October 2016.SAFER Study: Objectives & Components

Non-randomized40 couples

Observational Pilot

Study

Measure uptake

, adherence,

efficacy, outcomes

Qualitative

Interviews

Measure acceptability,

patient

& provider

experiences

and satisfaction

Cost-effectiveness analysis

Estimate costs associated

with delivering safer conception

Observational pilot study

How Couple chooses safer conception strategy(s) – Followed for 12 months of pregnancy attempts – Followed through pregnancy and delivery When Enrollment period: March 2017 – July 2017

Status: 10 couples screened, 8 couples enrolled Where UZ-UCSF Zengeza

CRS, Chitungwiza

SAFER

Study Protocol version 3.1 Dated 10 October 2016.

Inclusion Criteria

HIV-discordant in stable relationshipDesire to conceive and sexually activeMen ≥18 years; women 18 – 35 yearsNot pregnant, no serious infections (e.g. TB)Willing to use at least one safer conception strategy

Exclusion Criteria

History of infertility

On medication contraindicated with

PrEP

Study population

Inclusion Criteria

HIV-discordant in stable relationship

Desire to conceive and sexually

active

Men ≥18 years; women 18 – 35 years

Not pregnant,

no serious

infections (e.g. TB)

Willing to use at least one safer conception

strategy

SAFER

Study Protocol version 3.1 Dated 10 October 2016.

Adverse events

AEs and SAEs related to strategiesWill be documented on case report forms and reported to ethics committeesTemporary hold of strategy until event is stabilized or resolved

If Grade 3 or 4 toxicity with ARTs: Assess for alternate explanations Repeat testing within 72 hours for lab abnormalities, with weekly follow up

SAFER

Study Protocol version 3.1 Dated 10 October 2016.

Serum creatinine

Will be monitored at Month

1 and every 6 months

Elevation of ≥Grade 1 (and confirmed with 2

nd

test): Temporary hold of

PrEP

Elevation of ≥Grade 2 or calculated

CrCl

<50 mL/min: Temporary hold of

PrEP

and 2

nd

confirmatory test

Confirmed ≥Grade 2 or CrCl <50 mL/min: Permanent PrEP discontinuation

Summary of Visits

SAFER Study Protocol version 3.1 Dated 10 October 2016.Screening & enrollmentRun-in period (2 months)

Use of safer strategies (up to 12 months)Couples who conceive

Couples who do not conceive

Infertility evaluation

Pregnancy

(9 months)

Post-partum follow-up

(3 months)

Funding and support

Thank you… questions?

SAFER teamJoelle Brown, PIFelix Mhlanga, PI Bismark Mateveke, PIThandiwe Chirenda, Study CoordinatorGift Chareka, co

-InvestigatorMike Chirenje, co-InvestigatorNyaradzo Mgodi, co-Investigator Norma Mugwagwa, Medical OfficerCaroline Murombedzi

,

P

harmacist

Jim Kahn, co-Investigator

SAFER Study Team training, Harare, January 2017