A Key Link for Transmission Prevention

Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450189

Acronym

MP3

Enrollment

Registered

2011-10-12

Start date

2011-10-31

Completion date

2014-07-31

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Acute HIV, Transmission Prevention, Randomized Pilot study

Brief summary

This pilot study will assess the feasibility for the potential public health benefit of behavioral and antiretroviral interventions during acute HIV infection. Central Hypothesis The investigators hypothesize that delivering behavioral and antiretroviral interventions to acutely infected persons will reduce onward transmission.

Detailed description

The HIV epidemic in sub-Saharan Africa is severe and continues to grow. In urban areas of Malawi, 19% of pregnant women seeking antenatal care and 15.6% of Malawians aged 15-49 years were infected with HIV in 2007. Prevention interventions that prevent onward transmission of HIV are urgently needed. Persons with acute HIV infection (AHI) may be responsible for a substantial proportion of onward transmission of HIV infection. AHI is characterized by unfettered replication of HIV in a ramp up viremia. The high concentration of HIV in blood and genital secretions remains elevated for up to 10-12 weeks before it declines to the levels observed in established infection. These high levels of HIV shedding in the genital tract are likely to produce very efficient sexual transmission and the proportion of virions that are infectious may be substantially higher during acute compared to chronic infection. Consequently, the probability of transmission during unprotected intercourse for those with AHI is very high. Identifying persons with AHI and intervening to reduce onward transmission represents a tantalizing, but unproven, opportunity for HIV prevention. To have maximal impact, a prevention program targeting AHI must identify a substantial number of acutely infected persons and intervene quickly to minimize onward transmission. An effective immediate intervention would require behavioral modification to limit sexual partners and unprotected sex acts, and a biological intervention to reduce infectious viral burden in genital secretions. This is the first study to pilot a combined behavioral and biomedical intervention in individuals with AHI to reduce onward transmission of HIV.

Interventions

BEHAVIORALStandard HIV prevention messages

A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BEHAVIORALBI: Information-Motivation-Behavioral Skills Model

The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

DRUGRaltegravir

raltegravir (400 mg) administered orally twice daily for 12 weeks

DRUGemtricitabine/tenofovir disoproxil fumarate

emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Primary participants: * Acute HIV-1 infection * Men and women age greater than/= 18 years. * Intention to remain in the Lilongwe area for the duration of the study. * Ability and willingness of participant to provide informed consent. * Willingness to provide contact/locator information, be contacted, and asked to return for AHI results. Partner Participants: * Referred by a primary participant and present with a referral card. * Had vaginal or anal sex with a primary participant within 12 weeks prior to that primary participant's enrolling * Men and women age greater than/=18 years. * remain in the Lilongwe area for the duration of the study. * Ability and willingness of participant to provide informed consent.

Exclusion criteria

Primary Participants: * HIV infection based on two positive HIV antibody rapid tests at the time of screening. * HIV-negative based on one or more antibody rapid test and an HIV RNA PCR test. * Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization. * Active drug or alcohol use or dependence. * Current imprisonment or involuntary incarceration. * Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study. Partner Participants: * Active drug or alcohol use or dependence. * Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness. Exclusion for Receipt of Antiretroviral Drugs in the BIA Arm Note:A key component of this pilot study is to estimate the potential effect of ARVs during acute infection when applied on a large population scale.In effect, this pilot study should be viewed as a pilot for an effectiveness trial. Consequently, we will randomize all eligible participants to one of the three arms. If, however, persons should not receive ARVs for a variety of medically-related reasons, these persons will remain in the BIA arm, but will not receive ARVs. Women who are of reproductive potential but who refuse to use at least one form of contraception (see below), will remain in the BIA arm but will not receive ARVs. Similarly, persons randomized to the BI arm who do not attend all sessions will remain in the BI arm. Persons randomized to BIA with any of the following conditions will be excluded from receiving ARVs, but will remain in the BIA group for purposes of analysis. * Laboratory values obtained at Day 0 prior to initiating ARVs at a subsequent visit * Absolute neutrophil count \<300/mm3 * Hemoglobin \<8.0 g/dL * Platelet count \<40,000/mm3 * Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase \> 5 x upper limit of normal (ULN) * Total bilirubin \>2.5 x ULN * Creatinine Clearance (CrCl) \<60 mL/min * Hepatitis B surface antigen positivity * Positive serum or urine pregnancy test at Day 0. * Breastfeeding * Refusal to use at least one method of contraception, if a woman is of reproductive potential. Acceptable forms of contraception include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, intrauterine device (IUD), or a hormonal-based contraceptive. Women not meeting the reproductive potential criteria above may receive the study drugs without using contraception. * Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation. * Requirement for any current medications that are prohibited with any study drugs.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening	1 year	—
Prevalence of AHI Among Persons Screened	1 year	Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.
Proportion of Persons With AHI Successfully Recruited Into the Study	1 year	This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.
Proportion of Participants Completing Full Course of ARVs in Arm BIA	1 year	Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.	1 year	In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.
Proportion of Persons Completing All Scheduled Visits in Each Study Arm	1 year	—
Number of Adverse Events	one year	Mean number of adverse events per group

Secondary

Measure	Time frame	Description
Cumulative Incidence Herpes Simplex Virus Type 2	26 weeks	cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.
Number of Partners Reporting for HIV Testing	52 weeks	Number of partners per index reporting for HIV testing at any time during follow-up
Proportion of Partners Reporting for HIV Testing	52 weeks	Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants
Suppression of HIV RNA to <1000c/ml at 12 Weeks	12 weeks	Proportion of persons in each arm with viral load \<1000copies/ml at 12 weeks
Time to HIV RNA Suppression <1000 c/ml	From date of randomization until viral load suppression, up to 52 weeks	median time to viral load suppression (\<1000 c/ml)
Blood HIV RNA Concentration at Week 12	12 weeks	—
Blood HIV RNA Concentration at Week 26	26 weeks	—
Unprotected Sex Acts in Previous One Week - 12 Weeks	12 weeks	The mean number of unprotected sex acts in previous one week, assessed at 12 weeks
Genital HIV RNA Concentration - Week 12, Women	12 weeks	median HIV RNA concentration in cervical lavage fluid
Genital HIV RNA Concentration - Week 26, Women	26 weeks	median HIV RNA concentration in cervical lavage fluid
Genital HIV RNA Concentration - Week 52, Women	52 weeks	median HIV RNA concentration in cervical lavage fluid
Genital HIV RNA Concentration - Week 12, Men	12 weeks	median HIV RNA concentration as measured in semen
Genital HIV RNA Concentration - Week 26, Men	26 weeks	median HIV RNA concentration as measured in semen
Genital HIV RNA Concentration - Week 52, Men	52 weeks	median HIV RNA concentration as measured in semen
Blood HIV RNA Concentration at Week 52	52 weeks	—
Unprotected Sex Acts in Previous One Week - 26 Weeks	26 weeks	The mean number of unprotected sex acts in previous one week, assessed at 26 weeks
Unprotected Sex Acts in Previous One Week - 52 Weeks	52 weeks	The mean number of unprotected sex acts in previous one week, assessed at 52 weeks
Unprotected Sex Acts in Previous One Month - 12 Weeks	12 weeks	The mean number of unprotected sex acts in previous one month, assessed at 12 weeks
Unprotected Sex Acts in Previous One Month - 26 Weeks	26 weeks	The mean number of unprotected sex acts in previous one month, assessed at 26 weeks
Unprotected Sex Acts in Previous One Month - 52 Weeks	52 weeks	The mean number of unprotected sex acts in previous one month, assessed at 52 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	26 weeks	Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis

Countries

Malawi

Participant flow

Recruitment details

Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.

Pre-assignment details

Participants were evaluated in two stages: screening for acute HIV infection (AHI) and enrollment of persons with AHI for follow-up. As this is a pilot study, some outcomes refer to screening only. The original protocol called for 115 persons with AHI; only 46 persons were enrolled as the study period ended and funding expired.

Participants by arm

Arm	Count
Standard Counseling Arm The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection. Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.	9
Behavioral Intervention Arm The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.	18
Behavioral Intervention Plus Antiretrovirals (BIA) The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.	19
Total	46

Baseline characteristics

Characteristic	Standard Counseling Arm	Behavioral Intervention Arm	Behavioral Intervention Plus Antiretrovirals (BIA)	Total
Age, Continuous	31.6 years STANDARD_DEVIATION 8.1	26.7 years STANDARD_DEVIATION 5.1	27.1 years STANDARD_DEVIATION 7.9	27.7 years STANDARD_DEVIATION 7
Region of Enrollment Malawi	9 participants	18 participants	19 participants	46 participants
Sex: Female, Male Female	4 Participants	7 Participants	7 Participants	18 Participants
Sex: Female, Male Male	5 Participants	11 Participants	12 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	4 / 9	11 / 18	13 / 19
serious Total, serious adverse events	0 / 9	0 / 18	0 / 19

Outcome results

Primary

Number of Adverse Events

Mean number of adverse events per group

Time frame: one year

Arm	Measure	Value (MEAN)
Overall	Number of Adverse Events	0.78 number of events
Behavioral Intervention Arm	Number of Adverse Events	1.3 number of events
Behavioral Intervention Plus Antiretrovirals (BIA)	Number of Adverse Events	1.3 number of events

Primary

Prevalence of AHI Among Persons Screened

Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
Overall	Prevalence of AHI Among Persons Screened	0.0073 proportion of participants

Primary

Proportion of Participants Completing Full Course of ARVs in Arm BIA

Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that

Time frame: 1 year

Population: Number of persons in BIA arm eligible for study-provided ARVs

Arm	Measure	Value (NUMBER)
Behavioral Intervention Plus Antiretrovirals (BIA)	Proportion of Participants Completing Full Course of ARVs in Arm BIA	0.917 proportion of BIA participants

Primary

Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.

In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.

Time frame: 1 year

Population: All persons in the two behavioral intervention arms

Arm	Measure	Value (NUMBER)
Overall	Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.	0.216 proportion of participants

Primary

Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening

Time frame: 1 year

Population: All persons screened

Arm	Measure	Value (NUMBER)
Overall	Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening	0.622 proportion of participants screened

Primary

Proportion of Persons Completing All Scheduled Visits in Each Study Arm

Time frame: 1 year

Arm	Measure	Value (NUMBER)
Overall	Proportion of Persons Completing All Scheduled Visits in Each Study Arm	0.44 Proportion of participants
Behavioral Intervention Arm	Proportion of Persons Completing All Scheduled Visits in Each Study Arm	0.44 Proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Proportion of Persons Completing All Scheduled Visits in Each Study Arm	0.37 Proportion of participants

Primary

Proportion of Persons With AHI Successfully Recruited Into the Study

This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
Overall	Proportion of Persons With AHI Successfully Recruited Into the Study	0.69 Proportion of persons with AHI recruited

Secondary

Blood HIV RNA Concentration at Week 12

Time frame: 12 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Blood HIV RNA Concentration at Week 12	19411 copies/ml
Behavioral Intervention Arm	Blood HIV RNA Concentration at Week 12	22734 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Blood HIV RNA Concentration at Week 12	20 copies/ml

Secondary

Blood HIV RNA Concentration at Week 26

Time frame: 26 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Blood HIV RNA Concentration at Week 26	8661 copies/ml
Behavioral Intervention Arm	Blood HIV RNA Concentration at Week 26	58504 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Blood HIV RNA Concentration at Week 26	6788 copies/ml

Secondary

Blood HIV RNA Concentration at Week 52

Time frame: 52 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Blood HIV RNA Concentration at Week 52	3248.5 copies/ml
Behavioral Intervention Arm	Blood HIV RNA Concentration at Week 52	6467.5 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Blood HIV RNA Concentration at Week 52	10876 copies/ml

Secondary

Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.

Time frame: 52 weeks

Population: Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52

Arm	Measure	Value (NUMBER)
Overall	Cumulative Incidence Herpes Simplex Virus Type 2	0.5 Proportion of participants
Behavioral Intervention Arm	Cumulative Incidence Herpes Simplex Virus Type 2	1.0 Proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Cumulative Incidence Herpes Simplex Virus Type 2	0.3 Proportion of participants

Secondary

Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.

Time frame: 26 weeks

Population: Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26

Arm	Measure	Value (NUMBER)
Overall	Cumulative Incidence Herpes Simplex Virus Type 2	0.5 Proportion of participants
Behavioral Intervention Arm	Cumulative Incidence Herpes Simplex Virus Type 2	0.5 Proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Cumulative Incidence Herpes Simplex Virus Type 2	0.25 Proportion of participants

Secondary

Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

At least one incident infection with either gonorrhea, chlamydia or trichomoniasis

Time frame: 52 weeks

Population: Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26

Arm	Measure	Value (NUMBER)
Overall	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.14 proportion of participants
Behavioral Intervention Arm	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.42 proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.15 proportion of participants

Secondary

Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis

Time frame: 26 weeks

Population: Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests

Arm	Measure	Value (NUMBER)
Overall	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.14 proportion of participants
Behavioral Intervention Arm	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.33 proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)	0.12 proportion of participants

Secondary

Genital HIV RNA Concentration - Week 12, Men

median HIV RNA concentration as measured in semen

Time frame: 12 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 12, Men	25364 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 12, Men	446 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 12, Men	0 copies/ml

Secondary

Genital HIV RNA Concentration - Week 12, Women

median HIV RNA concentration in cervical lavage fluid

Time frame: 12 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 12, Women	82.5 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 12, Women	0 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 12, Women	38.5 copies/ml

Secondary

Genital HIV RNA Concentration - Week 26, Men

median HIV RNA concentration as measured in semen

Time frame: 26 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 26, Men	9456 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 26, Men	292 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 26, Men	0 copies/ml

Secondary

Genital HIV RNA Concentration - Week 26, Women

median HIV RNA concentration in cervical lavage fluid

Time frame: 26 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 26, Women	11.5 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 26, Women	0 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 26, Women	164 copies/ml

Secondary

Genital HIV RNA Concentration - Week 52, Men

median HIV RNA concentration as measured in semen

Time frame: 52 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 52, Men	13088 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 52, Men	66 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 52, Men	0 copies/ml

Secondary

Genital HIV RNA Concentration - Week 52, Women

median HIV RNA concentration in cervical lavage fluid

Time frame: 52 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

Arm	Measure	Value (MEDIAN)
Overall	Genital HIV RNA Concentration - Week 52, Women	0 copies/ml
Behavioral Intervention Arm	Genital HIV RNA Concentration - Week 52, Women	219 copies/ml
Behavioral Intervention Plus Antiretrovirals (BIA)	Genital HIV RNA Concentration - Week 52, Women	2111 copies/ml

Secondary

Number of Partners Reporting for HIV Testing

Number of partners per index reporting for HIV testing at any time during follow-up

Time frame: 52 weeks

Arm	Measure	Value (MEAN)
Overall	Number of Partners Reporting for HIV Testing	0.4 partners per index participant
Behavioral Intervention Arm	Number of Partners Reporting for HIV Testing	0.4 partners per index participant
Behavioral Intervention Plus Antiretrovirals (BIA)	Number of Partners Reporting for HIV Testing	0.4 partners per index participant

Secondary

Proportion of Partners Reporting for HIV Testing

Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants

Time frame: 52 weeks

Population: The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)

Arm	Measure	Value (NUMBER)
Overall	Proportion of Partners Reporting for HIV Testing	0.1 proportion of sex partners
Behavioral Intervention Arm	Proportion of Partners Reporting for HIV Testing	0.1 proportion of sex partners
Behavioral Intervention Plus Antiretrovirals (BIA)	Proportion of Partners Reporting for HIV Testing	0.1 proportion of sex partners

Secondary

Suppression of HIV RNA to <1000c/ml at 12 Weeks

Proportion of persons in each arm with viral load \<1000copies/ml at 12 weeks

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
Overall	Suppression of HIV RNA to <1000c/ml at 12 Weeks	0.5 Proportion of participants
Behavioral Intervention Arm	Suppression of HIV RNA to <1000c/ml at 12 Weeks	0.25 Proportion of participants
Behavioral Intervention Plus Antiretrovirals (BIA)	Suppression of HIV RNA to <1000c/ml at 12 Weeks	0.72 Proportion of participants

Secondary

Time to HIV RNA Suppression <1000 c/ml

median time to viral load suppression (\<1000 c/ml)

Time frame: From date of randomization until viral load suppression, up to 52 weeks

Arm	Measure	Value (MEDIAN)
Overall	Time to HIV RNA Suppression <1000 c/ml	39 weeks
Behavioral Intervention Arm	Time to HIV RNA Suppression <1000 c/ml	26 weeks
Behavioral Intervention Plus Antiretrovirals (BIA)	Time to HIV RNA Suppression <1000 c/ml	16 weeks

Secondary